WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2 (NCT03302494) | Clinical Trial Compass
TerminatedPhase 3
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
Stopped: Study closed due to device design modification
United States248 participantsStarted 2017-12-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation
✓. Indication for warfarin therapy with an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation
✓. Willing and able to comply with post-implant anticoagulation and antiplatelet regimen
✓. Willing to participate in the required follow-up visits and tests
✓. Subject has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB/EC at the site
Exclusion criteria
✕. Atrial fibrillation (AF) due to a reversible cause (e.g. thyrotoxicosis or postoperative)
✕. Known contraindication and/or allergy to warfarin, nickel, aspirin, intravenous contrast or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel), which cannot be adequately pre-medicated or desensitized
✕. Conditions other than AF requiring long-term anticoagulation therapy
✕. Contraindications for percutaneous catheterization procedures
✕. Prior surgical LAA occlusion/exclusion or implanted with LAA occlusion device, or any prior attempt of such procedures
What they're measuring
1
Percentage of Participants With Composite of All Cause Death, Procedure or Device Related Complications Requiring Percutaneous or Surgical Intervention or Major Bleeding
Timeframe: All death, procedure- or device-related complications requiring percutaneous or surgical intervention: From baseline up to 45 days; major bleeding: From baseline up to 5 years 11 months
2
Percentage of Participants With Composite of Ischemic Stroke or Systemic Embolism at 24 Months