WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2 (WAVECREST2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03302494|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2017
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Coherex WaveCrest® Left Atrial Appendage Occlusion System Device: Watchman® LAA Closure Device||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||If the subject is suspected of having a stroke since their most recent follow-up, a Neurologist blinded to subject's randomization and implanted device must evaluate the subject or otherwise provide rationale for why an in-person neurology visit and exam are unnecessary. Neurology or blinded trial personnel should also administer mRS & NIHSS if there is suspicion of stroke A Clinical Events Committee, also blinded to subject's randomization, will adjudicate primary safety and effectiveness.|
|Official Title:||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.|
|Actual Study Start Date :||December 27, 2017|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||December 1, 2028|
WaveCrest left atrial appendage occluder
Device: Coherex WaveCrest® Left Atrial Appendage Occlusion System
Percutaneous left atrial appendage closure
Active Comparator: Watchman (control)
Watchman left atrial appendage closure device
Device: Watchman® LAA Closure Device
Percutaeous left atrial appendage closure
- Procedure or device related complications [ Time Frame: 45 Days ]Part of the composite rate of the primary safety endpoint.
- All Death [ Time Frame: 24 months ]Part of the composite rate of the primary safety endpoint.
- Major Bleeding [ Time Frame: 24 months ]Part of the composite rate of the primary safety endpoint.
- Ischemic stroke, systemic embolism [ Time Frame: 24 months ]The primary effectiveness endpoint is a composite rate of ischemic stroke or systemic embolism at 24 months
- Ischemic stroke, systemic embolism [ Time Frame: 45 days ]The secondary endpoint is the rate of ischemic stroke or systemic embolism with the WaveCrest device in comparison to the CHADS2 and CHA2DS2-VASc imputed risk of ischemic stroke or systemic embolism in the absence of anticoagulant therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302494
|Study Chair:||Vivek Reddy, MD||MOUNT SINAI HOSPITAL|
|Study Chair:||Gregg Stone, MD||MOUNT SINAI HOSPITAL|