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Recruiting
NCT07287436
Elite AF IDE Trial (Elite AF)
Conditions: Atrial Fibrillation (AF), Stroke
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 400
Sponsor: Boston Scientific Corporation
Location: Arrhythmia Research Group Jonesboro Arkansas
Summary
The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for anticoagulation therapy to reduce the risk of stroke.
Eligibility Criteria
Inclusion Criteria:
1. The subject is of legal age to participate in the study per the laws of their respective geography.
2. The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
3. The subject has an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.
4. The subject is deemed to be suitable for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy following WATCHMAN Elite Device implant.
5. The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
6. The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
7. The subject is able and willing to return for required follow-up visits and examinations.
Exclusion Criteria:
1. The subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment upon study physician's discretion).
2. The subject has a documented life expectancy of less than 2 years.
3. The subject is currently enrolled, or plans to enroll, in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed.
4. The subject has a known contraindication to percutaneous catheterization procedure or is contraindicated for transesophageal echocardiography (TEE) or cardiac computed tomography (CT).
5. The subject has documented left ventricular ejection fraction (LVEF) \< 30%.
6. The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment.
7. The subject has a LAA anatomy that is incompatible with the device selection requirements outlined in the Instructions for Use (IFU).
8. The subject has a known hypercoagulability disorder, mechanical heart valve in any position, known amyloid cardiomyopathy, or recurrent deep vein thrombosis (DVT).
9. The subject has known history of complex atheroma with mobile plaque of the descending aorta and/or aortic arch.
10. The subject has estimated glomerular filtration rate (eGFR) \ 5mm, a significant mitral valve stenosis (i.e., MV area \ 15mm or length \> 15mm.
Source: ClinicalTrials.gov (NCT07287436). StuddyBuddy aggregates publicly available trial information.