Actively Recruiting
Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure
Led by OCEAN-SHD Study Group · Updated on 2025-08-15
500
Participants Needed
21
Research Sites
252 weeks
Total Duration
On this page
Sponsors
O
OCEAN-SHD Study Group
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 for 4 years from the time the first subject is enrolled in this study. * Participants will visit the hospital at 45 days, 1 year, and 2 years after enrollment, and will also be followed up by telephone, basically at the end of the observation period (up to a maximum follow-up of 4 years). \<Study treatment duration\> In both arms, OAC monotherapy will be initiated in the first 24 hours of enrollment and continued for 45 days (allowed window period: plus 2 weeks).. * SAPT arm will continue to receive 45 days of OAC monotherapy followed by low-dose aspirin (75~100 mg/day) as an antithrombotic agent required through the end of the study observation period. * NAPT arm do not receive antithrombotic medication after 45 days of OAC monotherapy through the end of the study observation period.
CONDITIONS
Official Title
Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has documented non-valvular atrial fibrillation without severe mitral stenosis or mechanical valves
- Patient has CHA2DS2-VA score of 2 or greater
- Patient meets guidelines for proper use of the left atrial appendage closure system including high bleeding risk
- Patient underwent successful Left Atrial Appendage Closure with no significant residual leak or major complications
- Patient is suitable for both Non-Antithrombotic and Single Antiplatelet Therapy as defined in the protocol
- Patient's left atrial appendage anatomy accommodates the Boston Scientific WATCHMAN FLX Pro device and procedure
- Patient and investigator agree patient will return for all required visits after LAAC
- Patient has provided written informed consent after understanding the study purpose
You will not qualify if you...
- Currently enrolled in other clinical trials except mandatory governmental or purely observational registries
- Require long-term anticoagulation for reasons other than atrial fibrillation-related stroke risk
- Require oral antiplatelet therapy for reasons other than LAAC
- Contraindicated for direct oral anticoagulants or vitamin K antagonists
- Contraindicated for aspirin or allergic to aspirin
- Have or scheduled for cardiac or noncardiac intervention or surgery 45 days before or 60 days after LAAC
- Stroke or transient ischemic attack within 30 days before enrollment
- Active bleeding
- No left atrial appendage or surgically ligated left atrial appendage
- Myocardial infarction within 30 days before enrollment
- Previous atrial septal repair or device for atrial septal defect/patent foramen ovale
- Mechanical valve prostheses at any site
- Known contraindications to transesophageal echocardiography
- Active infection
- New York Heart Association class IV congestive heart failure at enrollment
- Pregnant, breastfeeding, or planning pregnancy
- Expected life expectancy less than 2 years
- Require emergency surgery
- Other medical, social, or psychological conditions preventing consent or follow-up
- Investigator judgment that participation is inappropriate
AI-Screening
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Trial Site Locations
Total: 21 locations
1
Nagoya Heart Center
Nagoya, Aichi-ken, Japan, 461-0045
Actively Recruiting
2
Toyohashi Heart Center
Toyohashi, Aichi-ken, Japan, 441-8530
Actively Recruiting
3
New Tokyo Hospital
Matsudo, Chiba, Japan, 270-2232
Actively Recruiting
4
Kokura Kinen Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
Actively Recruiting
5
Gifu Heart Center
Gifu, Gifu, Japan, 500-8384
Actively Recruiting
6
Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
Sapporo, Hokkaido, Japan, 007-0849
Actively Recruiting
7
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan, 065-0033
Actively Recruiting
8
Tokai University Hospital
Isehara, Kanagawa, Japan, 259-1193
Actively Recruiting
9
St.Marianna University Hospital
Kawasaki, Kanagawa, Japan, 216-8511
Actively Recruiting
10
Sendai Kousei Hospital
Sendai, Miyagi, Japan, 981-0914
Actively Recruiting
11
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan, 710-8602
Actively Recruiting
12
The Sakakibara Heart Institute of Okayama
Okayama, Okayama-ken, Japan, 700-0804
Actively Recruiting
13
Kindai University Hospital
Ōsaka-sayama, Osaka, Japan, 589-8511
Actively Recruiting
14
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
15
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo, Japan, 101-8643
Actively Recruiting
16
Sakakibara Heart Institute
Fuchū, Tokyo, Japan, 183-0003
Actively Recruiting
17
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan, 173-8606
Actively Recruiting
18
IMS Tokyo Katsushika General Hospital
Katsushika-ku, Tokyo, Japan, 124-0025
Not Yet Recruiting
19
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan, 143-8541
Actively Recruiting
20
Keio University Hospital
Shinjuku-ku, Tokyo, Japan, 160-8582
Actively Recruiting
21
Toyama University Hospital
Toyama, Toyama, Japan, 930-0194
Actively Recruiting
Research Team
E
EPS Corporation
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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