Clinical Programme

WATCHMANTM

Clinical Programme

Clinical Trials and Registries

The WATCHMAN clinical programme consists of two randomised clinical trials and several prospective registries involving more than 3.400 patients.

1. Pilot Study

Meta-analyses confirmed that in cases of left atrial thrombus in non-rheumatic AF patients approximately 90% are in the left atrial appendage (LAA). This study assessed the feasibility of implanting a device in the LAA in patients with atrial fibrillation (AF) to prevent thromboembolic stroke.

The authors concluded that preliminary data suggest LAA occlusion with the WATCHMAN System is safe and feasible. 

Learn More:
Sick PB, Schuler G, Hauptmann KE, et al. Initial worldwide experience with the WATCHMAN Left Atrial Appendage System for stroke prevention in atrial fibrillation. J Am Col Cardiol. 2007;49(13):1490-1495.

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2. PROTECT AF Clinical Trial

The multicentre PROTECT AF study (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) was conducted to determine whether percutaneous left atrial appendage closure with a filter device (Watchman) was non-inferior to warfarin in reducing the risk of stroke in AF.

In the Journal of the American Medical Association article (4-year results), the authors concluded that after 3.8 years of follow-up among patients with non-valvular AF at elevated risk for stroke, percutaneous LAA closure met criteria for both non-inferiority and superiority, compared with warfarin, for preventing the combined outcome of stroke, systemic embolism, and cardiovascular death, as well as superiority for cardiovascular and all-cause mortality.

Learn More:
Holmes DR, Reddy VY, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009;374(9689):534-542.

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The multicentre PROTECT AF study (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) was conducted to determine whether percutaneous left atrial appendage closure with a filter device (Watchman) was non-inferior to warfarin in reducing the risk of stroke in AF.Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the WATCHMAN Left Atrial Appendage System for embolic protection in patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011;123(4):417-424.

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Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the WATCHMAN Left Atrial Appendage System for embolic protection in patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011;123(4):417-424.

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Reddy VY, Doshi SK, Sievert H, et al; and PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013;127(6):720-729.

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Reddy VY, Sievert H, Halperin J, et al; for the PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomised clinical trial. JAMA. 2014;312(19):1988-1998.

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Review WATCHMAN I: First Report of the 5-Year PROTECT-AF and Extended PREVAIL Results.

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3. CAP Registry

The Continued Access to PROTECT AF (CAP) Registry was a multicentre, prospective, non-randomised study allowing continued access to the WATCHMAN Device, following the PROTECT AF trial, during regulatory review of the pre-market application for the WATCHMAN Device. The primary objective of the CAP registry was to collect additional safety and effectiveness data on the WATCHMAN Device in subjects with non-valvular AF who are deemed by their physicians to be suitable for warfarin therapy.

Learn More:
Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011;123(4):417-424.

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4. PREVAIL Clinical Trial

The goal of the PREVAIL trial was to assess the safety and efficacy of LAA closure for stroke risk reduction in patients with non-valvular AF compared with long-term warfarin therapy.

Learn More:
Holmes DR Jr, Kar S, Price MJ, et al. Prospective randomised evaluation of the WATCHMAN Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL Trial. J Am Coll Cardiol. 2014;64(1):1-12.

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Reddy VY, 5-Year Outcomes After Left Atrial Appendage Closure From the PREVAIL and PROTECT AF Trials.
J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975

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5. ASAP Registry

The ASAP study, a non-randomised feasibility study performed outside the U.S., was designed to assess the safety and efficacy of Left Atrial Appendage Closure (LAAC) in non-valvular AF patients ineligible for warfarin therapy. 150 AF patients, contraindicated for long-term warfarin therapy were included in the ASAP study with an average CHADS2 score of 2.8%; and average CHA2DS2-VASc score of 4.4.

Given the mean CHADS2 score of 2.8, this equates to a predicted ischemic stroke rate of 7.4% per year using data from a cohort of hospitalized AF patients, assuming no aspirin use. If this expected stroke rate of 7.4% per year is averaged with data in which aspirin was used the expected ischemic stroke of the ASAP population is approximately 7.3%.

The ASAP study demonstrated a 77% reduction in ischemic stroke in patients who where contraindicated for warfarin vs aspirin alone and a 64% reduction vs aspirin and clopidogrel. LAAC with the WATCHMAN Device produced a significant reduction in the expected ischemic stroke rate for patients contraindicated to warfarin.

The 5 years follow-up of the ASAP registry has shown that OAC ineligible patients receiving the WATCHMAN device and short term dual anti-platelet therapy (DAPT) experienced 75% fewer ischemic strokes or systemic embolisms than expected if receiving aspirin alone2.

Learn More:
ASAP Registry, Reddy, et al. JACC.2013 Jun 25;61(25):2551-6

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ASAP 5 years data follow up letter, Sharma D. JACC 2016 May 10;67(18):2190-2192

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6. CAP2 Registry

The Continued Access to PREVAIL (CAP2) Registry is a multicentre, prospective, non-randomised study allowing continued access to the WATCHMAN Device, following the PREVAIL trial, during regulatory review of the pre-market application for the WATCHMAN Device. The primary objective of the CAP registry was to collect additional safety and effectiveness data on the WATCHMAN Device in subjects with non-valvular AF who are deemed by their physicians to be suitable for warfarin therapy.

All enrollments are complete and safety data has been presented and is available in the DFU. The study is still in active, on-going follow-up.

7. Long-Term Patient-Level Meta-Analysis

Five year results from a patient-level meta-analysis of the totality of data available on the WATCHMAN Device, by Reddy, et al, has been published in the Journal of American College of Cardiology (JACC). This publication includes 5-year outcomes of PREVAIL, combined with the 5-year outcomes of PROTECT-AF, and demonstrated that LAAC with Watchman provided stroke reduction in non-valvular atrial fibrillation comparable to warfarin, with additional reductions in major bleeding, particularly hemorrhagic stroke, and mortality.  

Learn More:
Reddy VY, 5-Year Outcomes After Left Atrial Appendage Closure From the PREVAIL and PROTECT AF Trials.
J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975

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8. EWOLUTION Registry

EWOLUTION (Registry on WATCHMANTM Outcomes in Real-Life Utilization) is the largest prospective real-life LAAC registry with over 1.000 patients studied. The EWOLUTION registry is a multicentre study designed to obtain clinical data on procedural success, complication rates, incidence of stroke, bleeding, and long-term patient outcomes.

Learn More:
Review the EWOLUTION peri-procedural outcomes:
Boersma LV, et al., Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J. 2016 Aug; 37(31):2465-74.

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Review the EWOLUTION 1 year results presentation on the DAPT subgroup:
Bergmann MW, et al., Safety and efficacy results in the EWOLUTION all-comers LAA closure study: DAPT subgroup. Presented at EuroPCR 2017 congress.

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Review EWOLUTION 3 month data:
Bergmann MW, et al., Safety and efficacy of early anticoagulation drug regimens after WATCHMAN left atrial appendage closure: three-month data from the EWOLUTION prospective, multicentre, monitored international WATCHMAN LAA closure registry. EuroIntervention. 2017 Sep 20;13(7):877-884. doi: 10.4244/EIJ-D-17-00042.

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