With over 500,000 patients implanted with the WATCHMAN Device Platform, CHAMPION-AF extends Boston Scientific's LAAC leadership by evaluating the WATCHMAN FLX Device as a safe and effective first-line option compared to non-vitamin K antagonist oral anticoagulants (NOACs) to reduce stroke risk.
500,000+
Lives changed—and counting
Recent studies
OPTION
The OPTION clinical trial is the first randomized, head-to-head study comparing left atrial appendage closure (LAAC) to oral anticoagulants (OACs)—95% of which were direct oral anticoagulants (DOACs)— following cardiac ablation to determine if LAAC with the WATCHMAN FLX™ LAAC Device is a reasonable alternative in patients after AFib ablation.†1
WATCHMAN FLX™ LAAC Device Pro pre-clinical data
The fluoropolymer-coated WATCHMAN FLX Pro showed significantly less thrombus and reduced inflammation in a challenging canine model. Mechanistic studies demonstrated that the WATCHMAN FLX Pro Device's albumin-binding properties led to reduced platelet activation, decreased inflammation, and greater endothelial coverage (EC).2
SURPASS
The SURPASS one-year outcomes analysis of the National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) Registry™ now includes the largest number of commercial WATCHMAN FLX Device patients to date. These data continue to support the best-in-class safety and long-term efficacy of the WATCHMAN FLX Device.3
Meta-analysis
The Meta-analysis, the largest comparison of peri-procedural success and short-term outcomes between the WATCHMAN FLX Device and the Amplatzer Amulet device, reveals superior procedural safety, higher procedural success, and better left atrial appendage (LAA) closure with the WATCHMAN FLX Device.4
SEAL FLX
SEAL FLX is the first study to compare the Amulet Device exclusively to the WATCHMAN FLX Device. The results demonstrated that the WATCHMAN FLX Device achieved statistically-superior complete occlusion.*5
PINNACLE FLX
The PINNACLE FLX investigational device exemption (IDE) trial was designed to establish the procedural safety and left atrial appendage closure efficacy of the WATCHMAN FLX LAAC Device.6
Active trials
CHAMPION-AF
SIMPLAAFY
SIMPLAAFY, a randomized, controlled trial, evaluates two monotherapy regimens compared to dual antiplatelet therapy (DAPT) after implantation of the WATCHMAN FLX Pro Device in patients with atrial fibrillation (AF). SIMPLAAFY aims to determine if a less intensive drug regimen may help mitigate post-implant bleeding risk and provide other viable post-implant treatment options.
Explore insights from other clinical trials
* Complete LAA occlusion defined as no visible peri-device leak (PDL) and absence of contrast patency in the distal LAA (LAA/left atrium Hounsfield ratio <0.25)
† Thermal AFib ablation only
References
1. 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.
2. Saliba et al. Enhanced Thromboresistance and Endothelialization of a Novel Fluoropolymer-Coated Left Atrial Appendage Closure Device, JACC: Clinical Electrophysiology, 2023.
3. 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.
4. Della Rocca et al, Procedural and Short-Term Follow-Up Outcomes of Amplatzer Amulet Occluder versus WATCHMAN FLX Device: A Meta-Analysis, Heart Rhythm 2022.
5. Korsholm-K et al. Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device. J Interv Card Electrophysiol. 2022 Aug 11. doi: 10.1007/s10840-022-01336-4.
6. Kar S, et al. Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Circulation. 2021;143:1754-1762.