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

Stopped early · Phase 3

Conditions studied: Stroke

In brief

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.

Key facts

Study ID: NCT03302494
Run by: Coherex Medical
People needed: 248
Starts: 2017-12-27
Expected to finish: 2023-12-21
Last updated by the study team: 2025-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation
At least 18 years of age
Calculated CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3
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

You may not qualify if…

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
Prior percutaneous or surgical closure of a patent foramen ovale or atrial septal defect
Inability or unwillingness to take oral anticoagulation for 45 days post-procedure
New York Heart Association (NYHA) Class IV heart failure
Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
History of symptomatic carotid, intervertebral, or intracranial artery occlusion or stenosis without revascularization with the exception of known occlusion without symptoms > 6 months
Modified Rankin Scale (mRS) score ≥ 4
Chronic resting heart rate ≥ 110 bpm
Congenital cardiac anomalies requiring cardiac surgery or interventional repair
Stroke or transient ischemic attack (confirmed by Neurologist) within 60 days prior to enrollment
Myocardial infarction within 60 days prior to enrollment
Sepsis or any infection requiring oral antibiotic therapy within 14 days or intravenous antibiotic therapy within 30 days prior to enrollment
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.
On renal replacement therapy, serum creatinine > 3.0 mg/dl (265 μmol/L) or calculated creatinine clearance < 25 ml/minute
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
Any medical disorder or psychiatric illness that would interfere with successful completion of the trial
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.
Subject belongs to a vulnerable population (see definition in Appendix I: Acronyms and Definitions)
Any condition that would reduce life expectancy to less than 2 years
Women of childbearing potential who are, or plan to become pregnant during the time of the trial (method of assessment per physician discretion)
Echocardiographic Exclusion Criteria

Where it is running

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

Full record on ClinicalTrials.gov

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