WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2 "WAVECREST2"

Not yet recruiting

Phase 3 Results N/A

Trial Description

The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.

Detailed Description

The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System. Subjects will be randomized in a 1:1 ratio to the Treatment Arm (Coherex WaveCrest LAA occlusion system) or the Control Arm (Boston Scientific's Watchman LAA occlusion system). The trial is designed to demonstrate that safety and effectiveness of the WaveCrest device are non-inferior to the Watchman device.

Conditions

Interventions

Outcomes

Type Measure Time Frame Safety Issue
Primary Procedure or device related complications 45 Days
Primary All Death 24 months
Primary Major Bleeding 24 months
Primary Ischemic stroke, systemic embolism 24 months

Sponsors