QT Studies for Biologics QT assessment in phase I Workshop 2
|
|
- Rolf Tucker
- 5 years ago
- Views:
Transcription
1 QT Studies for Biologics QT assessment in phase I Workshop 2 Philippe L Hostis Joint Conference of European Human Pharmacological Societies and 20th Anniversary of AGAH Berlin, 31st March 2011
2 QT assessment in Phase I Context TQT studies are not always possible or requested, but data on potential QTc prolongation must be available Reliable QT data is helpful to conduct the further drug development Increasing need for a deep evaluation of the effect of the compound on the cardiac repolarisation and QT interval during early development studies
3 QT assessment in Phase I The advantages Subject profile is adapted: healthy young volunteers Potential cardiac safety issues are well covered by safety studies Good quality of ECG recording in CPUs In ascending dose trials, the dose range is wider compared to an E14 TQT study (therap & supra-therap dose)
4 QT assessment in Phase I The disadvantages The parallel group design is usually preferred (no cross over) The use of a positive control to assay sensitivity is not possible The ideal practical conditions for ECG recording can be difficult to achieve in CPU due to conflict with other safety assessments: early development trials are safety studies. The evaluation of the QT interval cannot be considered as the priority. The sample size is too small to provide sufficient statistical power
5 QT assessment in Phase I The sample size is directly related to the QTc variability (average standard deviation observed on the study population) Decrease of the QTc variability is the key factor for reliable QT assessment in early phase trials Strategies to reduce QTc variability Enhance the quality of the recording Increase the amount of analysable ECG: Use adapted QT/QTc measurement methods
6 QT assessment in Phase I Quality of recording Use of adapted devices Practical conditions Subject preparation Subject environment Subject condition during recording Review of the schedule of safety assessments: Identification of resting periods Introduction of QT specific procedures On line monitoring of the quality of recording Automatic assessment Alert
7 Quality on-line monitoring Technical quality index: Noise level: low and high frequencies Electrode position Heart rate stability Twave amplitude Calculated for each ECG recorded Associated with alert systems ( ) and quality metrics
8 Quality on-line monitoring Quality score monitoring Quality score (mean value) M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 Time (month) Site 1 Site 2 Site 3 Helpful for Core Lab & CPU to implement corrective actions, additional training sessions,
9 Reduction of QTc variability It is necessary to have more analysable data: More timepoints More replicates More drug free ECG (advanced QTc methods) Feasibility: The workload for ECG collection must not be directly related to the number of ECG The methods for ECG analysis must be highly automated
10 Reduction of QTc variability Number of replicates Impact of replicates number on QTc variability 10 QTc variability Number of replicates Biotrial TQT study internal database The optimal number of replicates is 3 (classical cost/benefit approach), but can be increased with an highly automated method for collection and analysis
11 The QTcI approach has a significant impact on the QTc variability Reduction of QTc variability QT correction method Impact of QT correction on variability QT QTcB QTcF QTcI Variability (ms) Biotrial TQT study internal database
12 Reduction of QTc variability QT/RR relationship Biotrial TQT study internal database High number of drug free ECGs Wide RR range QT hysteresis included in the modelisation
13 Continuous ECG recording Increased amount of available ECG data due to continuous 12-lead ECG recordings Devices are small, patient and user friendly System is cost effective, easy to set-up and maintain Limitations concerning access to safety ECGs
14 Continuous ECG recording ECG 12D 10 seconds ECG Safety review Double-clip Electrodes QT assessment Holter 12D Continuous recording + ECG extracted A possible implementation for safety ECG collection and continuous ECG recording
15 Continuous ECG recording Possible optimisation of the time of extraction based on : Noise level Heart rate stability RR variation RR (ms) Time
16 Continuous ECG recording Definition of the optimal time of extraction within a time window around theoretical timepoint ECG 1 ECG 2 ECG 3 time
17 Continuous ECG recording Implementation of a fully automated reading method: Automatic algorithms are reliable if: the ECGs are normal (T wave morphology) the recording is of good quality Cardiologist significant corrections of the automatic measurements only on a limited part of the ECG
18 Automated QT reading method Selection of ECGs where the QT automatic measurement is not reliable enough Score: 0 -> 100 Quality (noise, baseline drift, electrodes placement, ) Variability Out of range values Particular T wave pattern
19 Automated QT reading method Low Score (reliable QT measurement):
20 Automated QT reading method High score (unreliable QT measurement):
21 Automated QT reading method Score distribution - Phase I study (820 ECG, YHV): 50% 45% 40% 120% 100% Distribution 35% 30% 25% 20% 15% 80% 60% 40% Cummulative 10% 5% 20% 0% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Quality score 0%
22 Automated QT reading method Score distribution - Phase I study: 25% 120% 20% 100% Distribution 15% 10% 80% 60% 40% Cummulative 5% 20% 0% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Quality score 0% 804 ECG, Elderly HV, 2 sites
23 Automated QT reading method Decision for manual reading based on score threshold: 50 QT measurement (ms) Automatic values Cardiologist values 3.5% ECG reviewed by cardiologist
24 Automated QT reading method Decision for manual reading based on score threshold: 30 QT measurement (ms) Automatic values Cardiologist values 23% ECG reviewed by cardiologist
25 QT assessment in Phase I Conclusion 24-hour Continuous ECG recording (pre dose and post dose) High quality recordings Highly automated QT measurement with adapted QTc method Reasonable QT assessment Exploratory data, provide guidance for further drug development
Data Quality in Small QTc Studies. Marek Malik, London
Data Quality in Small QTc Studies Marek Malik, London marek.malik@btinternet.com marek.malik@imperial.ac.uk Data Quality in Small QTc Studies DISCLAIMER Views and opinions presented are only my own Data
More informationJoint Annual meeting 2005 AGAH-Club Phase I
Joint Annual meeting 2005 AGAH-Club Phase I Early Drug Development Scientific and Regulatory challenges Strasbourg, March 17-18, 2005 Early drug development Scientific and Regulatory challenges QTc: Predictability,
More informationIndustry Experience of the Concentration-QTc Relationship in Phase 1 Studies. Corina Dota, AstraZeneca
Industry Experience of the Concentration-QTc Relationship in Phase 1 Studies Corina Dota, AstraZeneca CSRC-2 th February 2012 ICH E14 2.2.5 Alternative Strategies to Assess QT/QTc Interval Effects Alternatives
More informationSpeed - Accuracy - Exploration. Pathfinder SL
Speed - Accuracy - Exploration Pathfinder SL 98000 Speed. Accuracy. Exploration. Pathfinder SL represents the evolution of over 40 years of technology, design, algorithm development and experience in the
More informationIQ-CSRC PROSPECTIVE QTc STUDY Study Design and Choice of Drugs
IQ-CSRC PROSPECTIVE QTc STUDY Study Design and Choice of Drugs Nenad Sarapa, MD IQ-CSRC meeting, Silver Spring, MD 12 December 2014 Background SAD studies can reliably assess QTc prolongation if proper
More informationICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for nonantiarrhythmic
25 January 2016 EMA/CHMP/ICH/310133/2008 Committee for Human Medicinal Products ICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for nonantiarrhythmic
More informationbeyond AMPS LLC, New York, USA Hopital Lariboisiere, Paris, France
The Holter bin approach and beyond Fabio Badilini, PhD AMPS LLC, New York, USA Pierre Maison-Blanche, MD Hopital Lariboisiere, Paris, France 1 Outlines Background of quantitative digital ECG The rate RR
More informationQT Assessment: The new paradigm, but now what? Joy Olbertz PharmD, PhD Senior Director, Cardiovascular Safety Services
QT Assessment: The new paradigm, but now what? Joy Olbertz PharmD, PhD Senior Director, Cardiovascular Safety Services The Evolution of ICH E14 Points to Consider Joint Health Canada/FDA Concept Paper
More informationThe pharmacological positive control can be replaced by a meal.
The pharmacological positive control can be replaced by a meal. Wednesday, April 6th, 2016 CSRC/FDA Workshop: The Pro-arrhythmic Assessment of New Chemical Entities ACC Heart House Washington, D.C. Jorg
More informationGuidance for Industry
Reprinted from FDA s website by Guidance for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R1) U.S. Department
More informationFood can serve as a non pharmacological control in thorough cardiac safety studies
Food can serve as a non pharmacological control in thorough cardiac safety studies Jorg Taubel MD FFPM Washington 14 th April 2011 Disclaimer The views and opinions expressed in the following PowerPoint
More informationIMPLEMENTATION OF NOVEL ECG BIOMARKERS
IMPLEMENTATION OF NOVEL ECG BIOMARKERS CSRC CiPA meeting May 21, 2018 Washington DC Borje Darpo, MD, PhD, FESC Chief Scientific Officer, Cardiac Safety, ERT 1 Disclosures I work as a consultant for ERT,
More informationThe clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.
The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall
More informationDesign and Analysis of QT/QTc Studies Conceptional and Methodical Considerations Based on Experience
Design and Analysis of QT/QTc Studies Conceptional and Methodical Considerations Based on Experience Dr. Manfred Wargenau, Institute, Düsseldorf OVERVIEW Clinical background The ICH E14 guideline / review
More informationIQ/CSRC Study Waveform Sharing Program
IQ/CSRC Study Waveform Sharing Program Presentation for CSRC members August 26, 2015 Borje Darpo, icardiac Cindy Green, DCRI Georg Ferber, Independent Brian Smith, icardiac Jean-Philippe Couderc, THEW
More informationEditorial. The AMPS Quarterly Issue n.2-2q2009
The AMPS Quarterly Issue n.2-2q2009 Editors: Fabio Badilini PhD and Martino Vaglio AMPS-QT is a quarterly journal dedicated to all the people and organizations involved in the world of cardiac safety.
More informationAutomatic Pre-filling of DataFax CRFs. Why Pre-fill Forms?
Automatic Pre-filling of DataFax CRFs Name: Company: Email: Mark Williams Vice President CIO Applied Clinical Intelligence, LLC. mwilliams@a-ci.com Why Pre-fill Forms? When clinical electronic data and/or
More informationThe Maximum Mean Difference
The Maximum Mean Difference Statistical Problems in Assessing Cardiac Safety Georg Ferber, Novartis Pharma AG, Basel ROeS Seminar Bern, 10-13 Sep 2007 Overview QT prolongation some background The Thorough
More informationIs there an "Adequate" Heart Rate Correction for QT?
Is there an "Adequate" Heart Rate Correction for QT? R&D Information Technology, GGOIB Biometry&Biosignals Abbott GmbH&Co.KG D-67061 Ludwigshafen/Rhein International Biometric Society, German Region QT/QTc
More informationThe QT Interval Safety Endpoint for DR- TB trials. Kelly Dooley & Gary Maartens (Disclaimer: I know very little cardiac electrophysiology)
The QT Interval Safety Endpoint for DR- TB trials Kelly Dooley & Gary Maartens (Disclaimer: I know very little cardiac electrophysiology) The ECG tracing Physiology of a cardiac myocyte Flow of ions (Na
More informationRecent insights from the FDA QT-IRT on concentration-qtc analysis and requirements for TQT study ( waiver ) substitution
Recent insights from the FDA QT-IRT on concentration-qtc analysis and requirements for TQT study ( waiver ) substitution Dhananjay D. Marathe, Ph.D. QT-IRT Lead, Office of Clinical Pharmacology US FDA
More informationTQT studies - this is the end!
TQT studies - this is the end! Borje Darpo MD, PhD Associate Professor of Cardiology Chief Scientific Officer icardiac Technologies Yes as the only way to confidently exclude that a new drug has a clinically
More informationECG-PS ECG SIGNAL MEASUREMENT MODULE. Operation Manual. March 2005
ECG-PS ECG SIGNAL MEASUREMENT MODULE Operation Manual March 2005 2555 Collins Avenue, Suite C-5 - Miami Beach FL - 33140 - U.S.A. Phone #: (305) 534-5905 Fax: (305) 534-8222 e-mail: info@galix-gbi.com
More informationQT QT Study Design and Statistical Evaluation of QT Prolongation Introduction and QT Interval Correction
QT QT Study Design and Statistical Evaluation of QT Prolongation Introduction and QT Interval Correction Yasushi Orihashi Clinical Data and Biostatistics Department, Daiichi Sankyo Co., Ltd. email: orihashi.yasushi.c2@daiichisankyo.co.jp
More informationConcentration QTc Assessment in Early Phase Trials
Concentration QTc Assessment in Early Phase Trials Fang Liu*, Li Fan, Kuenhi Tsai, Devan V. Mehrotra ASA Biopharmaceutical Section Regulatory Industry Statistics Workshop September 14, 2018 Washington,
More informationBreakout #4 Phase 1 ECG:
Breakout #4 Phase 1 ECG: Potential Role of ECG under CiPA HESI CSRC CiPA Meeting Washington, DC - May 22, 2018 Jose Vicente, PhD Christine Garnett, PharmD Division of Cardiovascular and Renal Products
More informationFor Discussion Purposes Only
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 Step 1 Draft 2 (July 17, 2003) Draft 3 (November 12, 2003), Draft 4 (June 10, 2004)
More informationICH E14 THE CLINICAL EVALUATION OF QT/QTc INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS.
European Medicines Agency London, 25 May 2005 CHMP/ICH/2/04 ICH E14 THE CLINICAL EVALUATION OF QT/QTc INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS ICH Step 4 NOTE FOR
More informationRobust Detection of Atrial Fibrillation for a Long Term Telemonitoring System
Robust Detection of Atrial Fibrillation for a Long Term Telemonitoring System B.T. Logan, J. Healey Cambridge Research Laboratory HP Laboratories Cambridge HPL-2005-183 October 14, 2005* telemonitoring,
More informationFDA's Analysis and Interpretation of the IQ/CSRC Clinical Study
FDA's Analysis and Interpretation of the IQ/CSRC Clinical Study Jiang Liu Scientific Lead of QT-IRT Division of Pharmacometrics OCP/OTS/CDER/FDA Disclaimer: My remarks today do not necessarily reflect
More informationIQ-CSRC PROSPECTIVE STUDY RESULTS. Steve Riley, PharmD, PhD IQ-CSRC meeting December 12, 2014
IQ-CSRC PROSPECTIVE STUDY RESULTS Steve Riley, PharmD, PhD IQ-CSRC meeting December 12, 2014 IQ-CSRC prospective study - Design 20 male and female healthy subjects 3 treatment periods 9 subjects were to
More informationPacing in Drug Testing
ISHNE International Society for Holter and Noninvasive Electrocardiology 1 st Worldwide Internet Symposium on Drug- Induced QT Prolongation October 1-15, 1 15, 2007 Pacing in Drug Testing I Savelieva,
More informationPreparing for Changing Cardiac Safety Regulations. Joy Olbertz, PharmD, PhD
Preparing for Changing Cardiac Safety Regulations Joy Olbertz, PharmD, PhD Questions? Do I still have to assess proarrhythmic potential of my compound in a Thorough QT (TQT) study? If I have a TQT to conduct,
More informationPanorama. Arrhythmia Analysis Frequently Asked Questions
Panorama Arrhythmia Analysis Frequently Asked Questions What ECG vectors are used for Beat Detection? 3-wire lead set 5-wire lead set and 12 lead What ECG vectors are used for Beat Typing? 3-wire lead
More informationDefinitive QTc Assessment in Early Phase Trials: Expectations from FDA s Interdisciplinary Review Team
Definitive QTc Assessment in Early Phase Trials: Expectations from FDA s Interdisciplinary Review Team Jiang Liu, Ph.D. Scientific Lead for QT-IRT Division of Pharmacometrics Office of Clinical Pharmacology
More informationHSCRIBE 5 HOLTER ANALYSIS SYSTEM
HSCRIBE 5 HOLTER ANALYSIS SYSTEM freedom Your patients will be free to go about their miniature devices will let them forget they The H3+ digital recorder gives new meaning to the word compact, while providing
More informationPathfinder Holter Analyzer CARDIAC DIAGNOSTIC SOLUTIONS
Pathfinder Holter Analyzer CARDIAC DIAGNOSTIC SOLUTIONS Pathfinder Digital - An Evolution... Del Mar Reynolds rich history of innovation began nearly a half century ago with the development of Holter monitoring
More informationECG Rhythm Analysis by Using Neuro-Genetic Algorithms
MASAUM Journal of Basic and Applied Sciences, Vol. 1, No. 3, October 2009 522 ECG Rhythm Analysis by Using Neuro-Genetic Algorithms Safaa S. Omran, S.M.R. Taha, and Nassr Ali Awadh Abstract The heart is
More informationCardiovascular Safety Assessments in Early Phase Oncology Clinical Trials
CSRC Think Tank: Detection, Assessment and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development Cardiovascular Safety Assessments in Early Phase Oncology Clinical Trials Boaz Mendzelevski,
More informationImplications of methodological differences in digital electrocardiogram interval measurement B
Journal of Electrocardiology 39 (2006) S152 S156 www.elsevier.com/locate/jelectrocard Implications of methodological differences in digital electrocardiogram interval measurement B Fabio Badilini, PhD,
More informationEMA EFPIA workshop Breakout Session 2 Assessing the Probability of Drug-Induced QTc-Interval Prolongation During Early Clinical Drug Development
EMA EFPIA workshop Breakout Session 2 Assessing the Probability of Drug-Induced QTc-Interval Prolongation During Early Clinical Drug Development Oscar Della Pasqua GSK Background Drugs that prolong QT
More informationAssessment of Reliability of Hamilton-Tompkins Algorithm to ECG Parameter Detection
Proceedings of the 2012 International Conference on Industrial Engineering and Operations Management Istanbul, Turkey, July 3 6, 2012 Assessment of Reliability of Hamilton-Tompkins Algorithm to ECG Parameter
More informationEXPOSURE RESPONSE ANALYSIS TO EVALUATE A DRUG'S EFFECT ON ECG PARAMETERS
EXPOSURE RESPONSE ANALYSIS TO EVALUATE A DRUG'S EFFECT ON ECG PARAMETERS Christine Garnett, PharmD DCRP, FDA April 6, 2016 CSRC/FDA Workshop: The Proarrhythmic Assessment of New Chemical Entities Disclosures
More informationQUESTION: In a patient with different QT intervals, which one will give the highest prognostic accuracy? REPLY:
QUESTION: In a patient with different QT intervals, which one will give the highest prognostic accuracy? REPLY: First, there are two possibilities: I) It is not known, if the patient (subject) presented
More informationDelineation of QRS-complex, P and T-wave in 12-lead ECG
IJCSNS International Journal of Computer Science and Network Security, VOL.8 No.4, April 2008 185 Delineation of QRS-complex, P and T-wave in 12-lead ECG V.S. Chouhan, S.S. Mehta and N.S. Lingayat Department
More informationStudy Day 1 Study Days 2 to 9 Sequence 1 Placebo for moxifloxacin Study Days 2 to 8: placebo for pazopanib (placebopaz) 800 mg;
The study listed may include approved non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationAutomated Heart Analysis.
Automated Heart Analysis Yes, 5 minutes or less! Kardi is a revolutionizing non-invasive diagnostic tool used for testing ischaemic heart disease It s technology generates high quality 3D visuals projected
More informationCSRC White Papers. An update Dec. 2010
CSRC White Papers An update Dec. 2010 Ignacio Rodriguez, MD Clinical Safety Risk Management Roche ignacio.rodriguez.ir1@roche.com CSRC White Papers Position papers usually cover challenging areas of cardiovascular
More informationECG INTERPRETATION MANUAL
Lancashire & South Cumbria Cardiac Network ECG INTERPRETATION MANUAL THE NORMAL ECG Lancashire And South Cumbria Cardiac Physiologist Training Manual THE NORMAL ECG E.C.G CHECKLIST 1) Name, Paper Speed,
More informationDIFFERENCE-BASED PARAMETER SET FOR LOCAL HEARTBEAT CLASSIFICATION: RANKING OF THE PARAMETERS
DIFFERENCE-BASED PARAMETER SET FOR LOCAL HEARTBEAT CLASSIFICATION: RANKING OF THE PARAMETERS Irena Ilieva Jekova, Ivaylo Ivanov Christov, Lyudmila Pavlova Todorova Centre of Biomedical Engineering Prof.
More informationWelch Allyn HScribe Holter Analysis System
Welch Allyn HScribe Holter Analysis System CARDIOLOGY Freedom Empower your patients to go about their daily lives. The H3+ Digital Recorder gives new meaning to the word compact, while providing some of
More informationElectrocardiographic Markers Associated with Sotalol-induced Torsades de Pointes
Electrocardiographic Markers Associated with Sotalol-induced Torsades de Pointes Based on Data from the Telemetric and Holter ECG Warehouse (THEW) Initiative Jean-PhiIippe Couderc, PhD Center for Quantitative
More informationGuidance for Industry
Guidance for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs U.S. Department of Health and Human Services Food and Drug Administration
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationMARS Ambulatory ECG Analysis The power to assess and predict
GE Healthcare MARS Ambulatory ECG Analysis The power to assess and predict Connecting hearts and minds Prevention starts with knowledge Around the world, heart disease is one of our fastest-growing health
More informationDETECTION OF HEART ABNORMALITIES USING LABVIEW
IASET: International Journal of Electronics and Communication Engineering (IJECE) ISSN (P): 2278-9901; ISSN (E): 2278-991X Vol. 5, Issue 4, Jun Jul 2016; 15-22 IASET DETECTION OF HEART ABNORMALITIES USING
More informationQT prolongation and drug-drug interactions. Filip Josephson M.D., Ph.D Clinical Assessor Swedish Medical Products Agency
QT prolongation and drug-drug interactions Filip Josephson M.D., Ph.D Clinical Assessor Swedish Medical Products Agency Disposition Introduction to QT prolongation Three relevant DDI scenarios Concluding
More informationComparison of Two Highly Automated ECG Algorithms for Detection of Drug-Induced Cardiac Ion Channel Block
Comparison of Two Highly Automated ECG Algorithms for Detection of Drug-Induced Cardiac Ion Channel Block Marina Brockway 1, Anthony A. Fossa 2 and Jay W. Mason 3,4 US Food and Drug Administration (FDA)
More informationStopping rules for FIM trials
Stopping rules for FIM trials AGAH Workshop, 26 September 2013 Dr. Karin Göhler, Grünenthal GmbH Page 1 Relevant Guidelines EMEA/ CHMP/ SWP/ 294648/ 2007 Guideline on strategies to identify and mitigate
More informationTesting the Accuracy of ECG Captured by Cronovo through Comparison of ECG Recording to a Standard 12-Lead ECG Recording Device
Testing the Accuracy of ECG Captured by through Comparison of ECG Recording to a Standard 12-Lead ECG Recording Device Data Analysis a) R-wave Comparison: The mean and standard deviation of R-wave amplitudes
More informationNew ECG Biomarkers and their Potential Role in CiPA: Results and Implications
New ECG Biomarkers and their Potential Role in CiPA: Results and Implications HESI CSRC CiPA Meeting Washington, DC - May 21, 2018 Jose Vicente, PhD for the ECG Biomarker Working Group Division of Cardiovascular
More informationDirections for Use. CardioPerfect Webstation 2.0
Directions for Use CardioPerfect Webstation 2.0 Welch Allyn 4341 State Street Road Skaneateles Falls, NY 13153-0220 USA www.welchallyn.com European Regulatory Representative Welch Allyn Limited Navan Business
More informationA Study to Determine if T Wave Alternans is a Marker of Therapeutic Efficacy in the Long QT Syndrome
A Study to Determine if T Wave Alternans is a Marker of Therapeutic Efficacy in the Long QT Syndrome A. Tolat A. Statement of study rationale and purpose T wave alternans (TWA), an alteration of the amplitude
More informationErrors in manual measurement of QT intervals
386 Br Heart_J 1994;71:386-390 MEASUREMENT Regional Medical Physics Department, Freeman Hospital, Newcastle upon Tyne A Murray N B McLaughlin Academic Cardiology Department, Freeman Hospital, Newcastle
More informationQuick detection of QRS complexes and R-waves using a wavelet transform and K-means clustering
Bio-Medical Materials and Engineering 26 (2015) S1059 S1065 DOI 10.3233/BME-151402 IOS Press S1059 Quick detection of QRS complexes and R-waves using a wavelet transform and K-means clustering Yong Xia
More informationV4, V5 and V6 follow the 5 th intercostal space and are NOT horizontal as indicated in the image. Page 1 of 7
V4, V5 and V6 follow the 5 th intercostal space and are NOT horizontal as indicated in the image. Page 1 of 7 "Is it correct to place the electrodes under the female breasts?" Placement of electrodes directly
More informationCreating an alert for GSK vaccines in e-mds EHR
Immunization Alerts in e-mds Ensure timely and appropriate immunization orders and administration Keeping track of patient vaccination requirements is an important aspect in the delivery of ongoing patient
More informationAlbiglutide Does Not Prolong QTc Interval in Healthy Subjects: A Thorough ECG Study
Diabetes Ther (2014) 5:141 153 DOI 10.1007/s13300-014-0055-1 ORIGINAL RESEARCH Albiglutide Does Not Prolong QTc Interval in Healthy Subjects: A Thorough ECG Study Borje Darpo Meijian Zhou Jessica Matthews
More informationGenetic Algorithm based Feature Extraction for ECG Signal Classification using Neural Network
Genetic Algorithm based Feature Extraction for ECG Signal Classification using Neural Network 1 R. Sathya, 2 K. Akilandeswari 1,2 Research Scholar 1 Department of Computer Science 1 Govt. Arts College,
More informationIntravenous Conivaptan: Effects on the QTc Interval and Other Electrocardiographic Parameters in Healthy Volunteers
Advances in Therapy Volume 24 No. 2 March/April 2007 Intravenous Conivaptan: Effects on the QTc Interval and Other Electrocardiographic Parameters in Healthy Volunteers Kenneth C. Lasseter, MD Stacy C.
More informationDefibrillators TEC-8300K series. Improving quality of resuscitation
Defibrillators TEC-8300K series Improving quality of resuscitation Transitioning back to life For intensive treatment and advanced life support Pre-hospital Out-of-hospital 12-lead ECG acquisition and
More informationMULTILEAD SIGNAL PREPROCESSING BY LINEAR TRANSFORMATION
MULTILEAD SIGNAL PREPROCESSING BY LINEAR TRANSFORMATION TO DERIVE AN ECG LEAD WHERE THE ATYPICAL BEATS ARE ENHANCED Chavdar Lev Levkov Signa Cor Laboratory, Sofia, Bulgaria, info@signacor.com ECG signal
More informationEffect of Therapeutic and Supratherapeutic Doses of Vonoprazan on the QT/QTc Interval in a Phase I Randomized Study in Healthy Subjects
Citation: Clin Transl Sci (2017) 10, 208 216; C 2017 ASCPT. All rights reserved doi:10.1111/cts.12452 ARTICLE Effect of Therapeutic and Supratherapeutic Doses of Vonoprazan on the QT/QTc Interval in a
More informationThe Importance of CPR in Sudden Cardiac Arrest
The Importance of CPR in Sudden Cardiac Arrest By Adrian Waller, Public Safety Manager, ZOLL Medical. Feb 2011 The Importance of CPR in Sudden Cardiac Arrest By Adrian Waller, Public Safety Manager, ZOLL
More informationAUTOMATIC ANALYSIS AND VISUALIZATION OF MULTILEAD LONG-TERM ECG RECORDINGS
AUTOMATIC ANALYSIS AND VISUALIZATION OF MULTILEAD LONG-TERM ECG RECORDINGS Vessela Tzvetanova Krasteva 1, Ivo Tsvetanov Iliev 2 1 Centre of Biomedical Engineering Prof. Ivan Daskalov - Bulgarian Academy
More informationTolerability of Artemisinin based combination treatments - ACTs. Bob Taylor MD (Lond), FRCP (UK), DTM&H (Lond)
Tolerability of Artemisinin based combination treatments - ACTs Bob Taylor MD (Lond), FRCP (UK), DTM&H (Lond) Main ACTs Artesunate + mefloquine Dihydroartemisinin + piperaquine Artemether + lumefantrine
More informationChapter 9. Tests, Procedures, and Diagnosis Codes The McGraw-Hill Companies, Inc. All rights reserved.
Chapter 9 Tests, Procedures, and Diagnosis Codes Chapter 9 Content: Overview Ordering A Test SpringLabsTM & Reference Lab Results Managing and Charting Tests Creating A New Test Documenting and Activating
More informationAUTOMATED AUDITORY BRAINSTEM RESPONSE INFORMATION AND GUIDELINES FOR SCREENING HEARING IN BABIES
Last modified 12/08/02 www.nhsp.info/workbook.shtml Page 1 of 5 NEONATAL HEARING SCREENING AND ASSESSMENT AUTOMATED AUDITORY BRAINSTEM RESPONSE INFORMATION AND GUIDELINES FOR SCREENING HEARING IN BABIES
More informationWaterproof quality IP X4
Actual size Thanks to its high level of miniaturisation, the R.Test Evolution 3 is compact and lightweight (45 g. batteries included), for total discretion. Its exceptional design ensures high patient
More informationRecent Developments in the Analysis of QT Interval Data
Recent Developments in the Analysis of QT Interval Data Robb Muirhead Statistical Research & Consulting Center Pfizer Global Statistics Graybill Conference VII Colorado State University June 12, 2008 1
More informationA Protocol for Establishing Critical Power in Running
A Protocol for Establishing Critical Power in Running A Working Paper Prepared by The Stryd Team 27 September 201 1 Introduction One of the primary reasons for considering one s power consumption during
More information2011 to 2017 CET Test Plan Crosswalk
2011 to 2017 CET Test Plan Crosswalk Crosswalk Section: The following bridges tasks on the 2011 CET test plan with task statements on the 2017 CET test plan. 2011 NHA Test Plan TASK DESCRIPTION 2017 NHA
More informationInterpreting Adult Human Thorough QT Studies: Are They Relevant to Pediatric Safety?
Interpreting Adult Human Thorough QT Studies: Are They Relevant to Pediatric Safety? Hao Zhu, Ph.D. Scientific Lead, QT-IRT, FDA (Dec 10, 2010) Disclaimer: The views expressed in this talk are those of
More informationVarious Methods To Detect Respiration Rate From ECG Using LabVIEW
Various Methods To Detect Respiration Rate From ECG Using LabVIEW 1 Poorti M. Vyas, 2 Dr. M. S. Panse 1 Student, M.Tech. Electronics 2.Professor Department of Electrical Engineering, Veermata Jijabai Technological
More informationEstimation of the Power of the Food Effect on QTc to Show Assay Sensitivity
Drug Development Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity The Journal of Clinical Pharmacology 2018, 58(1) 81 88 C 2017, The Authors. The Journal of Clinical Pharmacology
More informationThe Cross-platform Application for Arrhythmia Detection
The Cross-platform Application for Arrhythmia Detection Alexander Borodin, Artem Pogorelov, Yuliya Zavyalova Petrozavodsk State University (PetrSU) Petrozavodsk, Russia {aborod, pogorelo, yzavyalo}@cs.petrsu.ru
More informationCARDIOVIT CS-200. The Gold Standard. Innovations are our passion. The CARDIOVIT CS-200 is the key to complete diagnostic services, including:
CARDIOVIT CS-200 The Gold Standard The CARDIOVIT CS-200 is the key to complete diagnostic services, including: 12-channel Resting ECG Automatic ECG measurements and interpretation (adult and pediatric)
More informationCARDIOVIT CS-200 Excellence. Designed for high-volume workload, equipped with the latest technology to save time and boost productivity
CARDIOVIT CS-200 Excellence Designed for high-volume workload, equipped with the latest technology to save time and boost productivity CARDIOVIT CS-200 EXCELLENCE Experience the CARDIOVIT CS-200 Excellence
More informationSVT Discriminators. Definition of SVT Discrimination. Identify which patient populations might benefit from these features
Definition of SVT Discrimination Identify which patient populations might benefit from these features Understand the 4 types of SVT discriminators used by St Jude Medical Be aware of programmable parameters
More informationA Health Shirt with ECG Real-time Display on Android Platform
A Health Shirt with ECG Real-time Display on Android Platform Zixiao Shen 1,2, Qingyun He 1, and Ye Li 1 1 Shenzhen Institutes of Advanced Technology, Chinese Academy of Science, Shenzhen 518055, China
More informationManual Defibrillators, Automatic External Defibrillators, Cardioversion, and External Pacing
Manual Defibrillators, Automatic External Defibrillators, Cardioversion, and External Pacing Key Points Defibrillators: - know the definition & electrical value of a joule - monophasic vs biphasic types:
More informationMEDILINK PEGASUS Smart. The New Portable ultrasound Bone densitometer
MEDILINK PEGASUS Smart The New Portable ultrasound Bone densitometer MEDILINK Specialised in Bone densitometry A subsidiary dedicated to Radiology Field Represented in more than 100 countries worldwide
More informationEctopic Beats, Activity Effects and Heart Rate Turbulence
HRV 2006 Ectopic Beats, Activity Effects and Heart Rate Turbulence Gari Clifford gari@mit.edu www.mit.edu/~gari/ Harvard-MIT Division of Health Sciences & Technology Outline Overview of Cardiovascular
More informationA hybrid wavelet and time plane based method for QT interval measurement in ECG signals
J. Biomedical Science and Engineering, 2009, 2, 280-286 doi: 10.4236/jbise.2009.24042 Published Online August 2009 (http://www.scirp.org/journal/jbise/). A hybrid wavelet and time plane based method for
More informationQT Interval: The Proper Measurement Techniques.
In the name of God Shiraz E-Medical Journal Vol. 11, No. 2, April 2010 http://semj.sums.ac.ir/vol11/apr2010/88044.htm QT Interval: The Proper Measurement Techniques. Basamad Z*. * Assistant Professor,
More informationSTOPPING RULES IN FIRST ENTRY INTO HUMAN STUDIES
STOPPING RULES IN FIRST ENTRY INTO HUMAN STUDIES Club Phase 1 Working Party: Alain Patat, Yves Donazzolo, Henri Caplain, Stephan Chalon, Michel Sibille Joint Conference of European Human Pharmacological
More informationAlgorithm for Premature Ventricular Contraction Detection from a Subcutaneous Electrocardiogram Signal
Portland State University PDXScholar Dissertations and Theses Dissertations and Theses Fall 12-12-2016 Algorithm for Premature Ventricular Contraction Detection from a Subcutaneous Electrocardiogram Signal
More informationAutomatic analysis of cardiac repolarization morphology using Gaussian mesa function modeling
Available online at www.sciencedirect.com Journal of Electrocardiology 41 (2008) 588 594 www.jecgonline.com Automatic analysis of cardiac repolarization morphology using Gaussian mesa function modeling
More informationAF monitoring and stroke: XPECT & REVEAL LINQ. Helmut Pürerfellner, Linz, Austria
AF monitoring and stroke: XPECT & REVEAL LINQ Helmut Pürerfellner, Linz, Austria 2 Medtronic Confidential 3 Circ Arrhythm Electrophysiol 2010;3:141-47 Reveal XT versus LINQ 5 Parameter Reveal XT Reveal
More informationECG Signal Characterization and Correlation To Heart Abnormalities
ECG Signal Characterization and Correlation To Heart Abnormalities Keerthi G Reddy 1, Dr. P A Vijaya 2, Suhasini S 3 1PG Student, 2 Professor and Head, Department of Electronics and Communication, BNMIT,
More information