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Recruiting 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 (\

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07840365). StuddyBuddy aggregates publicly available trial information.