Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure

Launched by OCEAN-SHD STUDY GROUP · Aug 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best way to prevent blood clots after a procedure called left atrial appendage closure (LAAC), which is done to lower stroke risk in people with a common heart rhythm problem called non-valvular atrial fibrillation. The study compares two approaches: one where patients take aspirin (a blood thinner) after 45 days of another blood thinner, and another where patients stop all blood thinners after those first 45 days. The main goal is to see if stopping blood thinners early is just as safe and effective as continuing aspirin, especially for people who have a high risk of bleeding.

People eligible for this study are adults with non-valvular atrial fibrillation who have successfully had the LAAC procedure and are at higher risk of bleeding. To join, patients must be able to take the study medications and agree to attend regular check-ups over up to 4 years. Participants will start taking blood thinners right after the procedure for about 45 days. After that, some will continue aspirin daily, while others will stop blood thinners completely. They will have follow-up visits at 45 days, 1 year, and 2 years, plus phone check-ins, to monitor their health. This study aims to find out if stopping blood thinners early can protect patients just as well, but with less risk of bleeding.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patient has documented non-valvular atrial fibrillation (i.e, atrial fibrillation without severe mitral stenosis or mechanical valves)
• • 2. Patient has CHA2DS2-VA score of 2 or greater
• • 3. Patient meets the guidelines for proper use of the left atrial appendage closure system including patient who has an increased risk of bleeding.
• • 4. Individual with nonvalvular atrial fibrillation who underwent successful LAAC (defined as no significant residual circumferential leak \[\>3 mm\] or major morbidity by the time of procedure completion).
• • 5. Patient suitable for pharmacotherapy as defined in this study protocol in both NAPT and SAPT arms
• • 6. LAA anatomy is accommodate Boston Scientific WATCHMAN FLX Pro and LAAC procedure
• • 7. The patient and the investigator and/or subinvestigator agree that the patient will return for all required VISITs after LAAC procedure
• • 8. Patient has thoroughly understood the purpose of the study and has provided written informed consent to participate in the study
• Exclusion Criteria:
• • 1. Patients who are currently enrolled in other clinical trials, except when the patient is participating in a mandatory governmental registries or purely observational registries with no associated treatment.
• • 2. Individuals require long-term anticoagulation therapy for reasons other than atrial fibrillation (AF)-related stroke risk reduction (e.g.,thrombophilic conditions, previous pulmonary embolism, or deep venous thrombosis).
• • 3. Patients requiring oral antiplatelet therapy for reasons other than LAAC (e.g.,history of myocardial infarction, history of endovascular treatment, history of stroke/transient ischemic attack, significant coronary stenosis proven by myocardial ischemia, severe carotid stenosis requiring invasive treatment,hematologic disease such as antiphospholipid syndrome or if the investigator and/or subinvestigator judged the need for antiplatelet therapy).
• • 4. Patients who meet one or more of the following criteria
• • Patients who are contraindicated for DOAC or VKA
• • Patients with a contraindication to aspirin
• • Patients diagnosed with an allergy to aspirin
• • 5. Those who have or are scheduled to undergo cardiac or noncardiac intervention or surgery 45 days or 60 days before or after LAAC (e.g.,cardioversion, PCI, cardiac ablation, cataract surgery, other structural heart interventions).
• • 6. Patients with stroke (either ischemic or hemorrhagic) or transient ischemic attack within 30 days prior to enrollment
• • 7. Patients with active bleeding
• • 8. Individuals who lack LAA or whose LAA has been surgically ligated
• • 9. Individuals who experienced a myocardial infarction (with or without intervention) recorded as a non-ST elevation myocardial infarction or ST elevation myocardial infarction in the 30-day period prior to enrollment
• • 10. Patients with previous atrial septal repair or with atrial septal defect/patent foramen ovale device
• • 11. Patients with mechanical valve prostheses at any site
• • 12. Persons with known contraindications to TEE
• • 13. Patients with active infection
• • 14. Individuals with NYHA class related IV congestive heart failure at enrollment
• • 15. Patients who are pregnant, breastfeeding, or wishing to become pregnant
• • 16. Patients with an expected life expectancy of less than 2 years
• • 17. Patients requiring emergency surgery for any reason
• • 18. Patients who, at the discretion of the investigator, have other medical, social, or psychological conditions that preclude adherence to appropriate consent or the follow-up tests required by the protocol
• • 19. Other patients whose investigator or subinvestigator judges their participation in the study to be inappropriate