Full Study Design
The PINNACLE FLX US IDE Trial was designed to establish the Procedural Safety and LAA Closure Efficacy with the WATCHMAN FLX LAAC Device.
- 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.