Active trials
CHAMPION-AF clinical trial
With over 500,000 patients implanted with the WATCHMAN Device Platform, CHAMPION-AF extends Boston Scientific’s leadership in LAAC by evaluating WATCHMAN FLX™ Left Atrial Appendage Closure Device as a safe and effective first-line option compared to a non-vitamin K antagonist oral anticoagulant (NOAC) for reducing stroke risk.*
SIMPLAAFY clinical trial
SIMPLAAFY is a randomized, controlled trial that will evaluate two monotherapy regimens compared to dual antiplatelet therapy (DAPT) after implantation of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device in patients, with atrial fibrillation (AF). SIMPLAAFY will assess whether a less intensive drug regimen may help mitigate post-implant bleeding risk and provide other viable options for post-implant treatment.†
Clinical trial results
OPTION clinical trial
The OPTION clinical trial is the first randomized, head-to-head study comparing LAAC to oral anticoagulants (OACs)—95% of which were direct oral anticoagulants (DOACs)—after cardiac ablation, to determine if LAAC with the WATCHMAN FLX Device is a reasonable alternative in patients after AFib ablation.1
SURPASS NCDR LAAO Registry
The SURPASS National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) Registry, assessed the safety and effectiveness of WATCHMAN FLX Device in contemporary clinical practice in the United States. This analysis supports the best-in-class safety of the WATCHMAN FLX Device with a 0.45% major procedural adverse event rate within seven days or hospital discharge, whichever is later; and 98% implant success in >97,000 real-world non-valvular atrial fibrillation (NVAF) patients.2
PINNACLE FLX clinical study
The PINNACLE FLX U.S. Investigational Device Exemption (IDE) trial was designed to establish the procedural safety and left atrial appendage closure efficacy of the WATCHMAN FLX Device.
Five-year patient-level meta-analysis
Reddy et al. published five-year results from a patient-level meta-analysis of all available data on the Legacy WATCHMAN™ Device in the Journal of the American College of Cardiology (JACC). The publication combines five-year outcomes from both PREVAIL and PROTECT-AF, demonstrating that LAAC with Legacy WATCHMAN Device reduces stroke in non-valvular atrial fibrillation comparably to warfarin, while also lowering major bleeding and mortality.3
Initial commercial experience data
Initial US Clinical Experience evaluates the acute procedural performance and complication rates for all Legacy WATCHMAN Device cases performed in the U.S., since FDA approval.
The authors concluded that, despite a large fraction of previously inexperienced operators, the procedural success in the real-world, post-FDA approval experience of the Legacy WATCHMAN Device was high and complication rates were low.4
CAP 2 registry
The Continued Access to PREVAIL (CAP2) Registry is a multi-center, prospective, non-randomized study allowing continued access to the Legacy WATCHMAN Device, following the PREVAIL trial, during regulatory review of the pre-market application for the Legacy WATCHMAN Device.
The primary objective of the CAP2 registry was to collect additional safety and effectiveness data on the Legacy WATCHMAN Device in patients with NVAF who were deemed by their physicians to be suitable for warfarin therapy.
PREVAIL clinical trial
The goal of the PREVAIL clinical trial was to assess the safety and efficacy of LAAC for stroke risk reduction in patients with NVAF, compared with long-term warfarin therapy.
The authors concluded that in this trial, LAA closure was non-inferior to warfarin for ischemic stroke risk reduction or systemic embolisms more than seven days post-procedure. Although non-inferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. Procedural safety was significantly improved.
This trial provided additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke risk reduction in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy.5
CAP registry
The Continued Access to PROTECT AF (CAP) Registry was a multi-center, prospective, non-randomized study allowing continued access to the Legacy WATCHMAN Device, following the PROTECT AF trial, during regulatory review of the pre-market application for the Legacy WATCHMAN Device.
The primary objective of the CAP registry was to collect additional safety and effectiveness data on the Legacy WATCHMAN Device in subjects with NVAF who were deemed by their physicians to be suitable for warfarin therapy.
PROTECT AF clinical trial
The multi-center PROTECT AF study was conducted to determine whether percutaneous LAAC with the Legacy WATCHMAN Device was non-inferior to warfarin for stroke risk reduction in atrial fibrillation.
In the Journal of the American Medical Association article (four-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 LAAC 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.6
Pilot study
Meta-analyses confirmed that in cases of left atrial thrombus in non-rheumatic atrial fibrillation (AF) patients, approximately 90% of them are in the LAA. This study assessed the feasibility of implanting a device in the LAA in patients with AF to prevent thromboembolic stroke.
The authors concluded that the preliminary data suggest that LAAC with the Legacy WATCHMAN Device is safe and feasible.7
Learn more about WATCHMAN FLX Pro Device
* 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. Not available for sale.
† WATCHMAN FLX Pro is an FDA approved device being studied for an expanded post-implant drug label for AF patients. The use of off-label post-implant drug regimens with the WATCHMAN FLX Pro device in AF patients is considered investigational.
CAUTION: Investigational Device. Limited by US law to investigational use only. Not available for sale. Full safety information can be found on bsci.com/simplaafy
References
1. Wazni et al. Left Atrial Appendage Closure after Ablation for Atrial Fibrillation, New England Journal of Medicine, November 2024.
2. Kapadia et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry, Circulation: Cardiovascular Interventions, July 2024.
3. Reddy VY, et al. JACC 2017; 70(24): 2964-2975.
4. Reddy VY, et al. JACC 2017; 69(3): 253-261.
5. Holmes DR Jr, Kar S, Price MJ, et al. Prospective randomized 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.
6. 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 randomized clinical trial. JAMA. 2014;312(19):1988-1998.
7. 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.