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NCT07840365
Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion
Conditions: Atrial Fibrillation (AF)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 234
Sponsor: Texas Cardiac Arrhythmia Research Foundation
Location: Texas Cardiac Arrhythmia Institute, St. David's Medical Center Austin Texas
Summary
This randomized study was designed to compare two antithrombotic regimens (long-term half-dose apixaban vs long-term aspirin after 45-days of full-dose apixaban) after successful Watchman implantation.
Eligibility Criteria
Inclusion Criteria:
* • Men and women ≥18 years of age;
* Patients who underwent a clinically successful LAA closure procedure with a Watchman device (device implanted without procedural or bleeding complication) within a day or are scheduled to undergo the LAAO procedure
* Paroxysmal, persistent, or permanent AF patients irrespective of prior antithrombotic treatment are eligible for randomization,
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
* Two or more clinical characteristics at baseline (age≥80 years, body weight ≤60 kg, serum creatinine ≥1.5 mg/dL) requiring apixaban dosage adjustment;
* Mechanical heart valves or valvular disease requiring surgery or interventional procedure;
* Mandatory indication for dual antiplatelet therapy (e.g. recent stent) or single anti-platelet treatment (SAPT) (e.g. high coronary risk);
* Any contra-indication or known allergy to aspirin or clopidogrel or apixaban;
* Any mandatory indication for anticoagulation for a reason other than AF (e.g. Pulmonary embolism);
* Ongoing major bleeding or complicated or recent (\
Source: ClinicalTrials.gov (NCT07840365). StuddyBuddy aggregates publicly available trial information.