Clinical Programme

WATCHMANTM

Clinical Programme


Clinical Trials and Registries

The WATCHMAN clinical programme consists of two concluded randomised clinical trials, two on-going randomised clinical trials and several prospective registries with over 15 years/6,000 patient years studied.


Trials Currently Enrolling

OPTION Clinical Trial

If you have patients that have had, or will have, an AF ablation and would like a non-pharmacological option for stroke risk reduction post-ablation, they may be eligible to participate in our OPTION trial.

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ASAP-TOO Clinical Trial

If you have patients that cannot take OACs, learn about our latest clinical trial ASAP-TOO.

Learn more:

Holmes, D. R., et al. (2017). "The Assessment of the Watchman Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO) trial." American Heart Journal 189: 68-74.

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FLXibility Study - Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Post approval study on WATCHMAN FLX to collect real world clinical outcomes with WATCHMAN FLX.


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.

View Abstract

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.

View Abstract

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.

View Abstract

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

View Abstract

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.

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

View Abstract

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.

View Abstract

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.

View Letter

Review EWOLUTION 2 years results Boersma LV et al., Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology. Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage. Circ Arrhythm Electrophysiol. 2019Apr;12(4):e006841.

Review EWOLUTION initial and long-term antithrombotic therapy after LAA Closure with WATCHMAN.

J. Ledwoch et al., Initial and long-term antithrombotic therapy after left atrial appendage closure with the WATCHMAN, EP Europace, Volume 22, Issue 7, July 2020, Pages 1036–1043.

View Abstract

Review EWOLUTION 2 years results Boersma LV et al., Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology. Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage. Circ Arrhythm Electrophysiol. 2019Apr;12(4):e006841.

Review EWOLUTION initial and long-term antithrombotic therapy after LAA Closure with WATCHMAN.

J. Ledwoch et al., Initial and long-term antithrombotic therapy after left atrial appendage closure with the WATCHMAN, EP Europace, Volume 22, Issue 7, July 2020, Pages 1036–1043.

View Abstract

9. PINNACLE FLX IDE Trial

PINNACLE FLX US IDE Clinical Trial  was designed to establish the procedural safety and closure efficacy of new generation LAAC device, WATCHMAN FLX.  

Learn More:
Review the PINNACLE FLX Trial results

View the results

Implanting Centres

Do you have a patient who may be a candidate for receiving the WATCHMAN FLX device?

Find An Implanting Centre in Your Area

CAUTION:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device.
Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries.
This material not intended for use in France.