Status:
COMPLETED
Coherex WAVECREST I Left Atrial Appendage Occlusion Study
Lead Sponsor:
Coherex Medical
Conditions:
Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation
LAA Anatomy Amenable to Treatment by Percutaneous Technique
Eligibility:
All Genders
18+ years
Brief 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 fibrillatio...
Detailed Description
Primary Safety Endpoint The primary safety endpoint is the incidence of major adverse events up to 45 days post-procedure. Major adverse events are defined as life-threatening incidents as determined ...
Eligibility Criteria
Inclusion
- Candidates for this study must meet ALL of the following 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
- 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.
- Cardioversion or ablation procedure planned in conjunction with or within 30 days after placement of the Coherex WaveCrest Left Atrial Appendage Occlusion System.
- Cardiac transplant or mechanical valve.
- Symptomatic carotid artery disease.
- Any medical disorder or psychiatric illness that would interfere with successful completion of the study as determined by the investigator.
- Conditions other than atrial fibrillation requiring long-term warfarin therapy.
- Resting heart rate \> 110 beats per minute (bpm).
- A single episode of transient atrial fibrillation.
- Thrombocytopenia (\<50,000 platelets/mm3), thrombocythemia (\>700,000 platelets/mm³), leucopenia (white blood cell count \< 3,000 cells/mm³), or anemia (hemoglobin concentration \< 10 gram per deciliter \[g/dl\]).
- Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints. (Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.)
- Any condition that would reduce life expectancy to less than two years from the date of the index procedure.
- Echocardiographic criteria for exclusion:
- Left ventricular ejection fraction (LVEF) \< 30%.
- Mitral valve stenosis \< 1.5 cm2 or any stenosis consistent with rheumatic valvular disease.
- Pericardial effusion \> 5 mm pre-procedure.
- Evidence of intracardiac thrombus visualized on TEE.
- Presence of a patent foramen ovale (PFO) that demonstrates a large shunt and/or atrial septal aneurysm with \> 10 mm excursion.
- Cardiac tumor.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT02239887
Start Date
October 1 2010
End Date
November 1 2014
Last Update
January 15 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.