WATCHMAN clinical evidence
Keep up with the latest WATCHMAN clinical evidence and learn why WATCHMAN is the #1 cardiologist-recommended LAAC device.
The most studied LAAC device in the world
With over 20 years of left atrial appendage closure (LAAC) innovation and experience, WATCHMAN has changed the lives of over 600,000 patients with proven, safe, and effective outcomes.
Proven*
10 years
FDA Approved
20+
Years of clinical evidence
Safe1
99%
Implant success rate†
0.5%
Major adverse event rate†1
Effective1
96.2%
Of patients discontinued OACs at 45 days
Explore Key WATCHMAN Trials
Complete
CHAMPION-AF
Seeks to demonstrate WATCHMAN FLX is a safe and effective first-line stroke risk reduction therapy for non-valvular AFib patients.‡
Explore the CHAMPION trial designComplete
OPTION
The first randomized, head-to-head study comparing WATCHMAN FLX to OACs (95% DOACs) after cardiac ablation.2
Explore OPTION trial dataComplete
PINNACLE FLX
A U.S. IDE clinical study designed to establish the procedural safety and LAA closure efficacy with the WATCHMAN FLX Implant.1
Explore PINNACLE FLX resultsComplete
SURPASS
The SURPASS analysis sought to assess long-term safety and efficacy outcomes with the WATCHMAN FLX device in a routine, real-world setting.3
Explore SURPASS real-world dataComplete
SURPASS Pro 45-day
Early 45-day outcomes with the WATCHMAN FLX Pro Device to reaffirm the proven performance of the WATCHMAN FLX platform.4
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* Represents all WATCHMAN models.
† Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA.
** Occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention.
‡WATCHMAN FLX is an FDA approved device being studied for an expanded indication as a first line therapy vs NOAC for AFib patients. The use of WATCHMAN as a first-line therapy for stroke risk reduction in AFib patients is considered investigational.
References
- Kar, S., et al, Primary Outcome Evaluation of the Next Generation LAAC Device: Results from the PINNACLE FLX Trial, Circulation, 2021.
- Wazni O, et al. Randomized Comparison of Left Atrial Appendage Closure with Oral Anticoagulation After Catheter Ablation for Atrial Fibrillation. Late Breaking Clinical Trial, American Heart Association 2024.
- Kapadia SR et al. Outcomes with the WATCHMAN FLX in Everyday Clinical Practice from the NCDR Left Atrial Appendage Occlusion Registry, Circulation: Cardiovascular Interventions, 2024.
- Piccini J et al. Outcomes with WATCHMAN FLX Pro in Everyday Clinical Practice: Early Results from SURPASS Pro, HRS 2025.
SH-2332707-AA