Actively Recruiting

Phase 4
All Genders
NCT07125417

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered 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

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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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