Left Atrial Appendage Closure Device
Built off the most studied, most implanted LAAC device in the world, WATCHMAN FLX is designed for patients with NVAF who are eligible for anticoagulation therapy to reduce the risk of stroke.
WATCHMAN FLX was studied in the PINNACLE FLX US IDE Clinical Trial. The study was designed to establish the procedural safety and closure efficacy of next generation LAAC device, WATCHMAN FLX.
PINNACLE FLX LATE-BREAKER PRESENTATION
Primary Outcome Evaluation of a Next Generation LAAC Device: The PINNACLE FLX Trial
presented by Dr. Shephal K. Doshi
May 8, 2020
HRS 2020 SCIENCE
PINNACLE FLX Clinical Study
- 400 patient, 29 US site, single arm, non-randomized trial evaluating WATCHMAN FLX for non-inferiority to safety and efficacy performance goals based on the WATCHMAN™ device.
- Follow-up: 45 days (+TEE), 6 months, 12 months (+TEE), 18 months, and 24 months
- Patient Characteristics: Average CHA2DS2-VASc of 4.2±1.5, Average HAS-BLED of 2.0±1.0
- Post Implant Drug Regimen: NOAC/ASA for 45 days, Clopidogrel/ASA to 6 months, ASA post 6 months
- Primary Safety Endpoint: All-cause death, ischemic stroke, systemic embolism, or device- or procedure-related adverse events requiring surgery or major endovascular intervention within 7 days following the procedure or by hospital discharge, whichever is later.
- Primary Efficacy Endpoint: The rate of effective LAA closure defined as any peri-device flow ≤5mm demonstrated by TEE at 12 months
- Secondary Efficacy Endpoint: The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
- Inclusion/exclusion criteria is consistent with WATCHMAN clinical study inclusion/exclusion criteria. Patients must be eligible for short-term NOAC vs warfarin in previous clinical studies.
Primary Safety Endpoints
Primary Efficacy Endpoints
The rate of effective LAA closure defined as any peri-device flow ≤5mm demonstrated by TEE at 12 months.
** Performance goal pased on the rates observed in PREVAIL(1) and CAP2(2), minus a clinically relevant delta
Designed to Treat Widest Range of Patient Anatomies
WATCHMAN FLX sizes range from (20mm - 35mm)
Discussion of the PINNACLE FLX Clinical Trial
Dr. Ian Meredith, Executive Vice President, Global Chief Medical Officer, Boston Scientific