None listed
Conditions
Brief summary
The primary study objective is to verify that under normal conditions of use the Coherex Left Atrial Appendage Occlusion System is a safe and effective LAA occlusion device. This investigation will be accomplished by: 1) implanting the device in patients with non-valvular paroxysmal, persistent, or permanent atrial fibrillation when anticoagulation is indicated for potential thrombus formation in the left atrium; 2) assessing LAA occlusion; and 3) monitoring adverse events at 45 days and/or up to one year post procedure. The study will also be designed to demonstrate the safety of the Coherex Left Atrial Appendage Occlusion System by assessing: 1) ease of successful device insertion; 2) positioning accuracy; 3) placement stability; and 4) post-procedure adverse events. To achieve this objective, data will be collected before, during, and after the procedure.
Interventions
The Coherex Left Atrial Appendage Occlusion System is a permanent implant to close the orifice of the left atrial appendage and will be placed during a one hour percutaneous transcatheter intervention. Post procedurte patients will be monitored for adverse events and in particular the occurance of thrombolic events originating from the left heart for a minimum of one year.
Sponsors
Coherex Medical Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age. 2. Diagnosis of paroxysmal, persistent, or permanent non-valvular atrial fibrillation. 3. 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. 4. Eligible for cessation of anticoagulation therapy if the LAA is sealed (i.e., the patient has no other condition requiring anticoagulation therapy). 5. Calculated CHADS score = 1. 6. Willingness to participate in the required follow-up visits and tests. 7. Willingness of patient or legal representative to provide written informed consent. 8. 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
1. Known contraindication and/or allergy to aspirin, clopidogrel, IV contrast, or nickel. 2. Extensive congenital cardiac anomalies, which can only be adequately repaired by cardiac surgery. 3. 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 cases have been completed. 4. New York Heart Association Class IV Congestive Heart Failure, defined as patients with severe physical limitations and symptoms even while at rest. 5. Myocardial infarction within the past three months. 6. Sepsis within one month prior to implantation or any systemic infection that cannot be successfully treated prior to device placement. 7. Presence of an atrial septal defect, atrial septal repair, or atrial septal closure device. 8. Female subjects who may be pregnant or are planning on becoming pregnant in the next year. 9. Cardioversion or ablation procedure planned in conjunction with or within 30 days after placement of the Coherex Left Atrial Appendage Occlusion System. 10. Cardiac transplant or mechanical valve. 11. Symptomatic carotid artery disease. 12. Any medical disorder or psychiatric illness that would interfere with successful completion of the study as determined by the investigator. 13. Conditions other than atrial fibrillation requiring long-term warfarin therapy. 14. Resting heart rate > 110 beats per minute (bpm). 15. A single episode of transient atrial fibrillation. 16. 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]). 17. 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.) 18. Any condition that would reduce life expectancy to less than two years from the date of the index procedure. Echocardiographic criteria for exclusion: 1. Left ventricular ejection fraction (LVEF) < 30%. 2. Mitral valve stenosis < 1.5 cm2 or any stenosis consistent with rheumatic valvular disease. 3. Pericardial effusion > 5 mm pre-procedure. 4. Evidence of intracardiac thrombus visualized on TEE. 5. Presence of a patent foramen ovale (PFO) that demonstrates a large shunt and/or atrial septal aneurysm with > 10 mm excursion. 6. Cardiac tumor.
Outcome results
None listed