Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure

Recruiting Phase 4 Interventional Study
Nonvalvular Atrial Fibrillation Aspirin Non-Antithrombotic Therapy High Bleeding Risk Left Atrial Appendage Closure
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
OCEAN-SHD Study Group · Other
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About This Trial
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 wi…
Trial Locations
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Eligibility Criteria
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 in…
Contacts

EPS Corporation

+81-6-7176-5731

prj-laac-napt@eps.co.jp

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