Clinical Trial Coverage Analysis Workshop Practice Device Study

Transcription

1 Clinical Trial Coverage Analysis Workshop Practice Device Study Aortic Valve Replacement in Extreme Risk Patients with Severe Aortic Stenosis Not Suitable for Standard Open Heart Surgery Replacement Protocol K567 Date and Version: 20 August 2014 (Version 1.0) Study Summary: To evaluate the safety and efficacy of the Kardia Optimal Valve Replacer (OVR) for the treatment of severe aortic stenosis in subjects not fit for standard replacement through open heart surgery IDE #: G12345 Category B FDA Approval Date: 07 June 2014 CMS CED Clinical Study Approval Date: 21 December 2014 Sponsor: Kardia, Inc. Primary Investigator: Emily K. Johnson, M.D PharmaSeek Financial Services, LLC d.b.a PFS Clinical. All rights reserved. Use and distribution prohibited except through written agreement with PharmaSeek Financial Services, LLC d.b.a. PFS Clinical. 1

2 1.0 Objective 1.1 Primary Objective The primary objective of the study is to evaluate the safety and effectiveness of the Kardia Optimal Valve Replacer (OVR) in patients excluded from standard aortic valve replacement through open heart surgery. 2.0 Study Information The purpose of this study is to find out what effects, good and/or bad, there are to treating severe aortic stenosis with an investigational aortic valve replacement device. Kardia s OVR is an investigational device currently being tested in a patient population not suitable for valve replacement through open heart surgery. It can be inserted using the less invasive transcatheter aortic valve replacement method (TAVR). Approximately 600 individuals, spread across 30 sites, will take part in this study. Every patient that meets the criteria for device implantation will receive the investigational device and continue to be followed for up to three years. If implantation with TAVR is unsuccessful, the subject will still be followed for three years at similar intervals to successful subjects. If deemed to be an acceptable candidate, study patients will receive the OVR and continue to be followed with blood tests, a physical exam, and scans at discharge. Following discharge, patients will be followed at one month, six months, and yearly until 36 months post implantation. 3.0 Study Criteria 3.1 Inclusion Criteria 1. Age 30 years and 85 years. 2. Confirmed and symptomatic severe aortic stenosis. 3. Agreement from at least one cardiologist and two cardiac surgeons prior to study enrollment and confirmed by primary investigator using screening results that 2015 PharmaSeek Financial Services, LLC d.b.a PFS Clinical. All rights reserved. Use and distribution prohibited except through written agreement with PharmaSeek Financial Services, LLC d.b.a. PFS Clinical. 2

3 current medical condition precludes patient from valve replacement through open heart surgery. 4. Adequate platelet count defined as: platelet count > 75,000 mcl. 5. Adequate international normalized ratio defined as INR < 2.0 prior to procedure. 6. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. 3.2 Exclusion Criteria 1. Prior history of failed aortic valve replacement. 2. Life expectancy < 6 months due to non-cardiac related condition. 3. Patients with severe dementia. 4. History of blood disorder and/or currently on a heparin regimen. 5. Currently on warfarin and unable to cease therapy beginning one week prior and one month post procedure. 6. Severe ventricular dysfunction with LVEF <20%. 7. Currently receiving or planning to receive future investigational agents. 4.0 Treatment Schedule All patients will receive the OVR device through the TAVR procedure. Study subjects (successful or unsuccessful) will continue with the follow-up tests. Study required tests are as follows: 4.1 Screening/Baseline Within 60 days prior to the tentative procedure, the following must occur to confirm initial eligibility: Signed informed consent, inclusion/exclusion criteria, demographics, and medical history Electrocardiogram (EKG) Transthoracic Echocardiogram (TTE) Computed Tomography (CT) Angiogram NIH Stroke Scale, quality of life (QOL) questionnaires, concomitant medication, and adverse events Spirometry (pre and post bronchodilator) Blood tests (CBC w/platelets, Creatinine, PT/INR, PTT, and B-type Natriuretic Peptide) Other blood tests at the discretion of the investigator 4.3 Implant Procedure 2015 PharmaSeek Financial Services, LLC d.b.a PFS Clinical. All rights reserved. Use and distribution prohibited except through written agreement with PharmaSeek Financial Services, LLC d.b.a. PFS Clinical. 3

4 Beginning on the day of implant procedure and continuing to one month post implant procedure, patients must begin taking Aspirin (300 mg per day). If the patient is taking warfarin, it must be discontinued at least one week prior to implant. Immediately prior to surgery, IV general anesthesia and Cefazolin (1 g) will be administered to the study subject. IV Cefazolin should also be administered six hours post procedure (1 g). If not already implanted in subjects, a temporary pacemaker will be placed inside the patient during the procedure. This is a necessary component of the procedure for the health and safety of the study subject. During the procedure the following tests and related services will take place: Placement of central venous line Blood tests (CBC w/platelets, Creatinine, PT/INR, and PTT) Other blood tests at the discretion of the investigator CT angiogram Fluoroscopy Contrast injections Cardiac catheterization Balloon valvuloplasty 4.4 Immediately Post-Procedure The following tests and medications will occur immediately following the procedure: NIH Stroke Scale, concomitant medications, and adverse events 4.5 Discharge (or at 10 days post-procedure) On the day of discharge or at 10 days post-procedure if not yet discharged, the following must occur: NIH Stroke Scale, concomitant medications, and adverse events Blood tests (CBC w/platelets) Other blood tests at the discretion of the investigator 4.6 Month 1 Follow-Up At one month following the procedure, the following tests must be completed: PharmaSeek Financial Services, LLC d.b.a PFS Clinical. All rights reserved. Use and distribution prohibited except through written agreement with PharmaSeek Financial Services, LLC d.b.a. PFS Clinical.

5 NIH Stroke Scale, QOL questionnaires, concomitant medications, and adverse events Spirometry (pre and post bronchodilator) 4.7 Month 6, 12, 24, 36 Follow-Up The following tests need to be completed at month six following the procedure, then yearly until three years post procedure: NIH Stroke Scale, QOL questionnaires, concomitant medications, and adverse events 5.0 Supportive Measures All patients must take Aspirin beginning on the day of procedure and continuing through one month post procedure as a blood thinning measure. One hour prior to the procedure and six hours post procedure, the patient must receive intravenous Cefazolin. Cefazolin, a Cephalosporin antibiotic will be used as a preventative measure for surgical wound infections that may occur during TAVR. 6.0 Criteria for Removal from Protocol Treatment 1. The patient may withdraw from the study at any time for any reason 2. Physician discretion 3. Death PharmaSeek Financial Services, LLC d.b.a PFS Clinical. All rights reserved. Use and distribution prohibited except through written agreement with PharmaSeek Financial Services, LLC d.b.a. PFS Clinical.

6 ß Screening/Baseline Implant Procedure Immediately Post-Procedure Discharge (or at 10 days postprocedure) Month 1 Month 6, 12, 24, 36 Physical Exam Informed Consent Inclusion/Exclusion Criteria Demographics & Medical History NIH Stroke Scale Quality of Life Questionnaires Concomitant Medications Adverse Events Laboratory CBC w/platelets Creatinine Other Lab Tests at the Discretion of the Investigator PT/INR, PTT B-Type Natriuretic Peptide (BNP) Scans/Procedures Electrocardiogram (EKG) Transthoracic Echocardiogram (TTE) Computed Tomography (CT) Angiogram Spirometry ß All laboratory tests must be performed pre-procedure. Discharge, or at 10 days post-procedure, whichever occurs first PharmaSeek Financial Services, LLC d.b.a PFS Clinical. All rights reserved. Use and distribution prohibited except through written agreement with PharmaSeek Financial Services, LLC d.b.a. PFS Clinical.