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โ† Trials
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Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure

RecruitingPhase 4Ages any - anyAllOCEAN-SHD Study Group
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to verify that Non-Antithrombotic Therapy (NAPT) followed by Oral Anticoagulants (OAC) monotherapy for 45 days after Left Atrial Appendage Closure (LAAC) is non-inferior to Single Antiplatelet Therapy (SAPT) with aspirin during the period from randomization to the end of observational period (4 years at the maximum) in non-valvular atrial fibrillation subjects with high bleeding risk. The primary endpoint is a composite endpoint consisting of all-cause mortality, myocardial infarction, stroke, systemic embolism, major bleeding, or clinically relevant non-fatal bleeding from randomization to the end of study observation (up to a maximum follow-up of 4 years). * Participants will be enrolled in this study until the day following the implementation of LAAC and will be randomized to the SAPT arm and NAPT arm in a 1:1 ratio. * Participants will be observed

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Single Antiplatelet Therapy or No Therapy (Control)
  • Non-Antithrombotic Therapy
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Where

21 sites
Nagoya Heart Center
Nagoya, Japan
Toyohashi Heart Center
Toyohashi, Japan
New Tokyo Hospital
Matsudo, Japan
Kokura Kinen Hospital
Kitakyushu, Japan
Gifu Heart Center
Gifu, Japan
Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
Sapporo, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Japan
Tokai University Hospital
Isehara, Japan

โ€ฆand 13 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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