CHAMPION-AF is the first and largest randomized controlled trial evaluating whether WATCHMAN is a reasonable alternative to NOACs in patients with non-valvular AFib. Learn how these findings support WATCHMAN as an option for stroke risk reduction without the bleeding risks of long-term OACs.3**
The most studied LAAC device in the world
The growing body of clinical evidence and meta-analysis of randomized data continue to reinforce the WATCHMAN Left Atrial Appendage Closure (LAAC) Implant as a proven, safe and effective alternative for atrial fibrillation (AFib) patients who can't, won't, or shouldn't take long-term oral anticoagulants (OACs).
With over 20 years of clinical evidence and innovation, the WATCHMAN Implant has changed the lives of over 600K AFib patients, protecting them from stroke risk without the bleeding risks associated with long-term OACs.
Proven
99%
Patients successfully implanted (395/400)*1
Safe
0.5%
Major adverse event rate†1
Effective
100%
Effective LAA closure‡1
Contemporary Meta-analysis of LAAC vs. OAC
A new meta-analysis of 7 randomized trials evaluating >7,000 patients with approximately 3 years of follow-up found that LAAC demonstrated comparable protection from stroke/systemic embolism and a 40% reduction in clinically significant bleeding, including procedural events, compared to OACs.2
These findings reinforce the strength of the WATCHMAN evidence base and support LAAC as an evidence-based alternative to long-term OAC for appropriate patients.
Annualized Ischemic Stroke Rate for Untreated AF Patients with CHA2DS2-VASc 3.9 vs Patients Receiving LAAC or NOACs2
▼40%
Relative reduction in clinically significant bleeding
(including procedural)
0.60 (0.36-0.98)
Proven patient outcomes
The WATCHMAN Implant is the most studied and implanted LAAC device in the world.§ Hear from cardiologists as they discuss the efficacy and clinical outcomes of the WATCHMAN Implant and see why it’s the leader in LAAC therapy.
Explore recent studies
CHAMPION-AF clinical trial: all endpoints met
OPTION clinical trial: primary endpoints met
OPTION is the first randomized, head-to-head study comparing WATCHMAN FLX to OACs (95% DOACs) after cardiac ablation. Explore how WATCHMAN demonstrated non-inferior efficacy and superior safety.4
SURPASS Pro early outcomes: reaffirming proven performance
Early outcomes with the WATCHMAN FLX Pro Device from the SURPASS Pro NCDR LAAO Registry reaffirm the proven performance of WATCHMAN FLX.5
Learn about the first and largest trial evaluating WATCHMAN vs. NOACs in patients with non-valvular AFib
*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.
‡LAA closure at 12 months is defined as any peri-device flow with jet size ≤5mm per core laboratory-assessed TEE
§Represents all WATCHMAN models.
**WATCHMAN FLX is an FDA approved device being studied for an expanded indication as a first line therapy vs NOAC for NVAF patients. The use of WATCHMAN or WATCHMAN FLX as a first-line therapy for stroke risk reduction in NVAF patients is considered investigational.
Caution: Investigational Device. Limited by US law to investigational use only.
References
1. Kar S, Doshi SK, et al. Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Circulation. 2021 May 4;143(18):1754-1762. doi: 10.1161/CIRCULATIONAHA.120.050117.
2. Turagam MK, Halperin JL, et al. Left Atrial Appendage Closure vs Anticoagulation for Stroke Prevention in Atrial Fibrillation: Meta-Analysis of Randomized Trials. JACC Clin Electrophysiol. 2026 Jul 6:S2405-500X(26)00639-0. doi: 10.1016/j.jacep.2026.06.033.
3. Doshi SK, Kar S, et al. Two-Year Outcomes With a Next-Generation Left Atrial Appendage Device: Final Results of the PINNACLE FLX Trial. J Am Heart Assoc. 2023 Feb 21;12(4):e026295. doi: 10.1161/JAHA.122.026295.
4. 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.
5. Piccini, J, Zeitler, E. P., et al. Outcomes with WATCHMAN FLX Pro in everyday clinical practice: Early results from SURPASS Pro. Heart Rhythm, 22(4, Suppl.), S318. Abstract PO-02-184. 2025.