Last updated on July 2019

Atrial Fibrillation

Brief description of study

Prospective, multicenter, randomized, active control, clinical trial of the Coherex WaveCrest Left Atrial Appendage (LAA) device compared to the Watchman® LAA device for the reduction in risk of ischemic stroke or systemic embolism in subjects with non-valvular atrial fibrillation who have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation.

Eligibility Criteria:

Inclusion Criteria
1. Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation
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 Institutional Review Board/Ethics Committee (IRB/EC) at the site

Exclusion Criteria
1. Atrial fibrillation (AF) due to a reversible cause (e.g. thyrotoxicosis or post-operative)
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 atrial fibrillation requiring long-term anticoagulation therapy
4. Contraindications to 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 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 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 planned 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 gram/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)

Clinical Study Identifier: TX133597

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Baptist Health Lexington Clinical Research Center

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