WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
NCT ID: NCT03302494
Last Updated: 2025-03-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
248 participants
INTERVENTIONAL
2017-12-27
2023-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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WaveCrest
WaveCrest left atrial appendage occluder
Coherex WaveCrest® Left Atrial Appendage Occlusion System
Percutaneous left atrial appendage closure
Watchman (control)
Watchman left atrial appendage closure device
Watchman® LAA Closure Device
Percutaeous left atrial appendage closure
Interventions
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Coherex WaveCrest® Left Atrial Appendage Occlusion System
Percutaneous left atrial appendage closure
Watchman® LAA Closure Device
Percutaeous left atrial appendage closure
Eligibility Criteria
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Inclusion Criteria
2. At least 18 years of age
3. Calculated CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3
4. Indication for warfarin therapy with an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation
5. Willing and able to comply with post-implant anticoagulation and antiplatelet regimen
6. Willing to participate in the required follow-up visits and tests
7. 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
2. 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
3. Conditions other than AF requiring long-term anticoagulation therapy
4. Contraindications for percutaneous catheterization procedures
5. Prior surgical LAA occlusion/exclusion or implanted with LAA occlusion device, or any prior attempt of such procedures
6. Prior percutaneous or surgical closure of a patent foramen ovale or atrial septal defect
7. Inability or unwillingness to take oral anticoagulation for 45 days post-procedure
8. New York Heart Association (NYHA) Class IV heart failure
9. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
10. History of symptomatic carotid, intervertebral, or intracranial artery occlusion or stenosis without revascularization with the exception of known occlusion without symptoms \> 6 months
11. Modified Rankin Scale (mRS) score ≥ 4
12. Chronic resting heart rate ≥ 110 bpm
13. Congenital cardiac anomalies requiring cardiac surgery or interventional repair
14. Stroke or transient ischemic attack (confirmed by Neurologist) within 60 days prior to enrollment
15. Myocardial infarction within 60 days prior to enrollment
16. Sepsis or any infection requiring oral antibiotic therapy within 14 days or intravenous antibiotic therapy within 30 days prior to enrollment
17. Surgical or interventional cardiovascular and non-cardiovascular procedure including cardioversion within 30 days prior to enrollment or AF ablation within 60 days prior to enrollment or any planned general surgery or interventional procedure within 90 days after enrollment or any planned cardiac surgery.
18. On renal replacement therapy, serum creatinine \> 3.0 mg/dl (265 μmol/L) or calculated creatinine clearance \< 25 ml/minute
19. Thrombocytopenia (\<60,000 platelets/mm3), leucopenia (white blood cell count \< 3,000 cells/mm³), or anemia (hemoglobin concentration \< 10 grams/deciliter) based on blood work done within 30 days prior to enrollment
20. Any medical disorder or psychiatric illness that would interfere with successful completion of the trial
21. Currently participating in an investigational drug trial or another device trial that has not completed the primary endpoint (trials requiring extended follow-up for products that are commercially available are not considered investigational trials). Concurrent enrollment in the ACC LAAO Registry is permitted.
22. Subject belongs to a vulnerable population (see definition in Appendix I: Acronyms and Definitions)
23. Any condition that would reduce life expectancy to less than 2 years
24. Women of childbearing potential who are, or plan to become pregnant during the time of the trial (method of assessment per physician discretion)
1. Left ventricular ejection fraction \< 30%
2. Mitral valve stenosis defined as valve area \< 1.5cm2, mean gradient \> 6mmHg, or any valve deformity consistent with rheumatic valvular disease
3. Aortic valve stenosis defined as valve area ≤1.0cm2 or mean gradient \>30mmHg
4. Circumferential pericardial effusion \> 10mm or symptomatic pericardial effusion
5. Evidence of intracardiac thrombus
6. Cardiac tumor or myxoma
7. Atrial septal defect that warrants closure
8. Complex atheroma in the ascending aorta or aortic arch as evidenced by mobile plaque
9. Left Atrial Appendage size and shape are unsuitable for closure with a WaveCrest or Watchman device
18 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Coherex Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Vivek Reddy, MD
Role: STUDY_CHAIR
MOUNT SINAI HOSPITAL
Gregg Stone, MD
Role: STUDY_CHAIR
MOUNT SINAI HOSPITAL
Locations
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Grandview Medical Center
Birmingham, Alabama, United States
Dignity Health Mercy Gilbert Medical Center
Chandler, Arizona, United States
Pacific Heart Institute / St. John's Health Center
Los Angeles, California, United States
Medstar Heart and Vascular Institute - Washington Hospital Center
Washington D.C., District of Columbia, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Wellstar Kennestone
Marietta, Georgia, United States
Baptist Health Lexington
Lexington, Kentucky, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Marquette General Hospital
Marquette, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
Northwell Health
Bay Shore, New York, United States
New York University- NYU Langone Cardiac
New York, New York, United States
New York University
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Ohio State University
Columbus, Ohio, United States
UPMC Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, United States
Heart Hospital Baylor Plano (Baylor Research Institute)
Plano, Texas, United States
Christus Trinity Clinic Research
Tyler, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Monash Health
Melbourne, , Australia
St. Vincent's Hospital
Sydney, , Australia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CHX_IP014
Identifier Type: -
Identifier Source: org_study_id
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