EP Clinical Research Program Summary. Daniel L Lustgarten MD PhD Associate Professor The University of Vermont School of Medicine
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1 EP Clinical Research Program Summary Daniel L Lustgarten MD PhD Associate Professor The University of Vermont School of Medicine
2 Financial Disclosures Consultant and/or Research Support: Medtronic Biosense Webster Cardiofocus St Jude Guidant/Boston Scientific
3 EP Clinical Research Program EP : Cardiovascular Electrophysiology: Subspecialty of Cardiology Focus: Rhythm disturbances
4 EP Clinical Research Program Broadly speaking we study two major areas: Implantable Cardiac Devices Ablation Procedures
5 EP Clinical Research Program Since starting the Clinical EP Research Program in 2002: 17 Multicenter Trials 2 Center-based Data registries
6 EP Clinical Research Program 9 of these are still enrolling or in the follow up phase
7 EP Clinical Research Program One of these trials is our own investigator initiated study
8 Clinical EP Research Program Structure We have a team of 5 research nurses in Cardiology Directed by Michaelanne Rowen One of whom is EP dedicated
9 The Studies Fund the Program The vast majority of these studies are Industry Funded
10 Vetting Process Contract Negotiation: OSP (The Black Box) Investigational Research Board review
11 What are these studies? Drug Studies Novel Anticoagulants Novel Antiarrhythmia Agents
12 What are these studies? Device related: Pre-Market Approval Studies Expanding indications of established devices Novel Cardiac Device Safety and Efficacy Studies
13 Example of One Currently Enrolling Study: PREVAIL Novel Cardiac Device Safety and Efficacy Studies: A Device designed to reduce the risk of stroke associated with Atrial Fibrillation while eliminating the need for concomitant blood thinning drugs:
14 Background: Atrial Fibrillation and stroke Up to 20% of all strokes are believed to be attributable to Atrial Fibrillation (AF) About 160,000 AF CVA yearly in the US Direct/Indirect costs AF-CVA annually: $14.75 billion American Heart Association. Heart Disease and Stroke Statistics 2010 Update. Dallas, Texas: American Heart Association; , American Heart Association.
15 AF and stroke Stroke associated with AF is associated with the highest morbidity and mortality AF-strokes 50% more likely to have permanent deficit c/w non-af strokes Lamassa et al. Stroke. 2001;32:
16 AF and stroke Stroke risk is reduced by 64% with adjusted-dose warfarin therapy vs no therapy 30-40% reduction vs aspirin Hart et al Ann Intern Med 2007;146:
17 AF and stroke The Left Atrial Appendage has been identified as the predominant cardiac embolic source (>90%) (TEE and autopsy studies) Blackshear JL, Odell JA. Ann Thorac Surg :
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20 The Watchman Device:
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23 Autopsy 9 mos Canine 45 days
24 PREVAIL FDA-mandated Comparison of Watchman vs Coumadin 440 AF Patients at particularly high risk for stroke 2:1 randomization Device to coumadin 1 efficacy endpoints: Stroke, cardiovascular death, or systemic embolism 1 safety endpoints: Pericardial effusion, device embolization, stroke, hemorrhage
25 PREVAIL This is a follow-up to a similar prior trial called PROTECT-AF FDA had safety concerns about the implant process Wanted bigger numbers Wanted some new centers to participate
26 FAHC 12 patients enrolled thus far: 2 roll-in patients (Watchman device implanted) 7 implants 3 randomized to stay on coumadin (total of 35 enrolling centers, to date 234 pts enrolled, we are the 7the highest enrolling center, the second highest of the new centers)
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32 PREVAIL: Potential Candidates and: Patients with AF able to tolerate coumadin Male Age > 75 Female > 65 HTN Diabetes Prior Stroke Structural heart disease
33 Why do we do this? 1) Patients gain access to cutting edge technology and treatments 2) As an academic medical center we participate and contribute to advances in medicine 3) Educational tool for our trainees 4) Provides funding for nursing salaries, fellowship support, institutional overhead
34 Fin Daniel L Lustgarten MD PhD Associate Professor The University of Vermont School of Medicine
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