NCT07840365 Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion
| NCT ID | NCT07840365 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Texas Cardiac Arrhythmia Research Foundation |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 234 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2028-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 234 participants in total. It began in 2026-09-01 with a primary completion date of 2028-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 (\<72hours) major surgery; * Recent myocardial infarction (\<6 weeks); * Recent TE event (\<6 weeks) * Recent Intracranial bleeding (\< 6 months); * Prasugrel or ticagrelor concomitant use * Participating in an investigational drug or another device trial within the previous 30 days; * High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical; * Pregnancy or within 48 hours post-partum or breast feeding women; * Patient under legal protection.
Contact & Investigator
Andrea Natale, MD
PRINCIPAL INVESTIGATOR
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Frequently Asked Questions
Who can join the NCT07840365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07840365 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 234 participants.
Is NCT07840365 currently recruiting?
Yes, NCT07840365 is actively recruiting participants. Contact the research team at mitra.mohanty@stdavids.com for enrollment information.
Where is the NCT07840365 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT07840365 clinical trial?
NCT07840365 is sponsored by Texas Cardiac Arrhythmia Research Foundation. The principal investigator is Andrea Natale, MD at Texas Cardiac Arrhythmia Institute, St. David's Medical Center. The trial plans to enroll 234 participants.
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