Phase
Condition
Atrial Fibrillation
Arrhythmia
Chest Pain
Treatment
Non-Antithrombotic Therapy
Single Antiplatelet Therapy or No Therapy (Control)
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient has documented non-valvular atrial fibrillation (i.e, atrial fibrillationwithout severe mitral stenosis or mechanical valves)
Patient has CHA2DS2-VA score of 2 or greater
Patient meets the guidelines for proper use of the left atrial appendage closuresystem including patient who has an increased risk of bleeding.
Individual with nonvalvular atrial fibrillation who underwent successful LAAC (defined as no significant residual circumferential leak [>3 mm] or major morbidityby the time of procedure completion).
Patient suitable for pharmacotherapy as defined in this study protocol in both NAPTand SAPT arms
LAA anatomy is accommodate Boston Scientific WATCHMAN FLX Pro and LAAC procedure
The patient and the investigator and/or subinvestigator agree that the patient willreturn for all required VISITs after LAAC procedure
Patient has thoroughly understood the purpose of the study and has provided writteninformed consent to participate in the study
Exclusion
Exclusion Criteria:
Patients who are currently enrolled in other clinical trials, except when thepatient is participating in a mandatory governmental registries or purelyobservational registries with no associated treatment.
Individuals require long-term anticoagulation therapy for reasons other than atrialfibrillation (AF)-related stroke risk reduction (e.g.,thrombophilic conditions,previous pulmonary embolism, or deep venous thrombosis).
Patients requiring oral antiplatelet therapy for reasons other than LAAC (e.g.,history of myocardial infarction, history of endovascular treatment, historyof stroke/transient ischemic attack, significant coronary stenosis proven bymyocardial ischemia, severe carotid stenosis requiring invasivetreatment,hematologic disease such as antiphospholipid syndrome or if theinvestigator and/or subinvestigator judged the need for antiplatelet therapy).
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
Those who have or are scheduled to undergo cardiac or noncardiac intervention orsurgery 45 days or 60 days before or after LAAC (e.g.,cardioversion, PCI, cardiacablation, cataract surgery, other structural heart interventions).
Patients with stroke (either ischemic or hemorrhagic) or transient ischemic attackwithin 30 days prior to enrollment
Patients with active bleeding
Individuals who lack LAA or whose LAA has been surgically ligated
Individuals who experienced a myocardial infarction (with or without intervention)recorded as a non-ST elevation myocardial infarction or ST elevation myocardialinfarction in the 30-day period prior to enrollment
Patients with previous atrial septal repair or with atrial septal defect/patentforamen ovale device
Patients with mechanical valve prostheses at any site
Persons with known contraindications to TEE
Patients with active infection
Individuals with NYHA class related IV congestive heart failure at enrollment
Patients who are pregnant, breastfeeding, or wishing to become pregnant
Patients with an expected life expectancy of less than 2 years
Patients requiring emergency surgery for any reason
Patients who, at the discretion of the investigator, have other medical, social, orpsychological conditions that preclude adherence to appropriate consent or thefollow-up tests required by the protocol
Other patients whose investigator or subinvestigator judges their participation inthe study to be inappropriate
Study Design
Connect with a study center
Nagoya Heart Center
Nagoya, Aichi 461-0045
JapanActive - Recruiting
Toyohashi Heart Center
Toyohashi, Aichi 441-8530
JapanActive - Recruiting
New Tokyo Hospital
Matsudo, Chiba 270-2232
JapanActive - Recruiting
Kokura Kinen Hospital
Kitakyushu, Fukuoka 802-8555
JapanActive - Recruiting
Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
Sapporo, Hokkaido 007-0849
JapanActive - Recruiting
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido 065-0033
JapanActive - Recruiting
Tokai University Hospital
Isehara, Kanagawa 259-1193
JapanActive - Recruiting
St.Marianna University Hospital
Kawasaki, Kanagawa 216-8511
JapanActive - Recruiting
Sendai Kousei Hospital
Sendai, Miyagi 981-0914
JapanActive - Recruiting
Kurashiki Central Hospital
Kurashiki, Okayama 710-8602
JapanActive - Recruiting
Kindai University Hospital
Osaka sayama, Osaka 589-8511
JapanActive - Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
JapanActive - Recruiting
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo 101-8643
JapanActive - Recruiting
Sakakibara Heart Institute
Fuchu, Tokyo 183-0003
JapanActive - Recruiting
Teikyo University Hospital
Itabashi-ku, Tokyo 173-8606
JapanActive - Recruiting
IMS Tokyo Katsushika General Hospital
Katsushika-ku, Tokyo 124-0025
JapanSite Not Available
Toho University Omori Medical Center
Ota-ku, Tokyo 143-8541
JapanActive - Recruiting
Keio University Hospital
Shinjuku-ku, Tokyo 160-8582
JapanActive - Recruiting
Gifu Heart Center
Gifu, 500-8384
JapanActive - Recruiting
The Sakakibara Heart Institute of Okayama
Okayama, 700-0804
JapanActive - Recruiting
Toyama University Hospital
Toyama, 930-0194
JapanActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.