Atrial Fibrillation

  • STATUS
    Recruiting
  • sponsor
    Coherex Medical, Inc.
Updated on 3 December 2020
aspirin
stroke
heart failure
warfarin
ticagrelor
vascular disease
warfarin therapy
cardioversion
transient ischemic attack
embolism
anticoagulation therapy

Summary

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.

Details
Condition Atrial Fibrillation, Atrial Fibrillation (Pediatric)
Clinical Study IdentifierTX133597
SponsorCoherex Medical, Inc.
Last Modified on3 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Institutional Review Board/Ethics Committee (IRB/EC) at the site

Exclusion Criteria

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