No blood-thinners versus aspirin after left atrial appendage closure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with nonvalvular atrial fibrillation and high bleeding risk who undergo successful left atrial appendage closure are randomized 1:1 to either single antiplatelet therapy with aspirin or a non-antithrombotic strategy with a short course of oral anticoagulant for 45 days. Enrollment occurs up to the day after the LAAC procedure and participants are followed for up to four years. The primary outcome is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, major bleeding, or clinically relevant non-fatal bleeding from randomization through the observation period. The trial focuses on patients whose LAA anatomy accommodates the WATCHMAN FLX Pro device and who meet predefined safety and follow-up requirements.

Why it matters

Who can join: the full rules

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

Where it's running

• Nagoya Heart Center
  Nagoya, Aichi-ken, Japan Recruiting
• Toyohashi Heart Center
  Toyohashi, Aichi-ken, Japan Recruiting
• New Tokyo Hospital
  Matsudo, Chiba, Japan Recruiting
• Kokura Kinen Hospital
  Kitakyushu, Fukuoka, Japan Recruiting
• Gifu Heart Center
  Gifu, Gifu, Japan Recruiting
• Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
  Sapporo, Hokkaido, Japan Recruiting

Study contacts

• Study coordinator: EPS Corporation
• Email: prj-laac-napt@eps.co.jp
• Phone: +81-6-7176-5731

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.