Coherex WAVECREST I Left Atrial Appendage Occlusion Study (NCT02239887) | Clinical Trial Compass
CompletedNot Applicable
Coherex WAVECREST I Left Atrial Appendage Occlusion Study
155 participantsStarted 2010-10
Plain-language summary
Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular atrial fibrillation in patients who are at increased risk for embolic stroke and have an ongoing indication for oral anticoagulation.
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
✓. At least 18 years of age.
✓. Diagnosis of paroxysmal, persistent, or permanent non-valvular atrial fibrillation.
✓. Indicated for long-term anticoagulation therapy including patients on anticoagulants and patients with a contraindication to anticoagulation. The first 30 patients must have a contraindication to anticoagulation.
✓. Eligible for cessation of anticoagulation therapy if the LAA is sealed (i.e., the patient has no other condition requiring anticoagulation therapy).
✓. Calculated CHADS score ≥ 1.
✓. Willingness to participate in the required follow-up visits and tests.
✓. Willingness of patient or legal representative to provide written informed consent.
✓. Female subjects of child-bearing potential must have a negative serum pregnancy test within 7 days prior to the index procedure, and must be willing to use reliable contraception methods for one year post-procedure.
Exclusion criteria
✕. Known contraindication and/or allergy to aspirin, clopidogrel, IV contrast, or nickel.
✕. Extensive congenital cardiac anomalies, which can only be adequately repaired by cardiac surgery.
✕. Stroke or transient ischemic attack (TIA), as diagnosed by a neurologist, within the past 30 days. Patients with a history of stroke or TIA will not be allowed to enroll until 30 days post stroke or TIA have been completed.
✕. New York Heart Association Class IV Congestive Heart Failure, defined as patients with severe physical limitations and symptoms even while at rest.
✕. Myocardial infarction within the past three months.
✕. Sepsis within one month prior to implantation or any systemic infection that cannot be successfully treated prior to device placement.
✕. Presence of an atrial septal defect, atrial septal repair, or atrial septal closure device.
✕. Female subjects who may be pregnant or are planning on becoming pregnant in the next year.