Trials / Terminated
TerminatedNCT03302494
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2. A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the Coherex WaveCrest® Left Atrial Appendage Occlusion System Compared to the Watchman® LAA Closure Device for the Reduction in Risk of Ischemic Stroke or Systemic Embolism in Subjects With Non-valvular Atrial Fibrillation That Have an Appropriate Rationale to Seek a Non-pharmacologic Alternative to Chronic Oral Anticoagulation.
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 248 (actual)
- Sponsor
- Coherex Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Coherex WaveCrest® Left Atrial Appendage Occlusion System | Percutaneous left atrial appendage closure |
| DEVICE | Watchman® LAA Closure Device | Percutaeous left atrial appendage closure |
Timeline
- Start date
- 2017-12-27
- Primary completion
- 2023-12-21
- Completion
- 2023-12-21
- First posted
- 2017-10-05
- Last updated
- 2025-03-12
- Results posted
- 2025-03-12
Locations
25 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03302494. Inclusion in this directory is not an endorsement.