A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure
Status unconfirmed · Phase 4
Conditions studied: Non-Valvular Atrial Fibrillation, Left Atrial Appendage Closure
In brief
This is a single arm, open label, single site study assessing the feasibility of post-procedural edoxaban therapy in atrial fibrillation (AF) patients after clinically indicated WATCHMAN left atrial appendage (LAA) closure.
Key facts
- Study ID
- NCT03088072
- Run by
- Scripps Health
- People needed
- 75
- Starts
- 2017-03-23
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2017-07-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The patient has documented paroxysmal, persistent, or permanent non-valvular AF (i.e., the patient has not been diagnosed with rheumatic mitral valve disease).
- LAA closure with the WATCHMAN device is planned
- The patient fulfills the FDA indication for WATCHMAN LAA closure
- The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial
- The patient is able and willing to return for required follow-up visits and examinations.
- The patient is 18 years of age or older
You may not qualify if…
- Conditions other than atrial fibrillation that require anti-coagulation (e.g., a prosthetic heart valve)
- Stroke within the previous 7 days
- Hypersensitivity to edoxaban
- Moderate or severe mitral stenosis
- A need for aspirin at a dose of >81 mg a day
- A need for on-going treatment with dual antiplatelet therapy with aspirin and clopidogrel
- A need for on-going treatment with ticagrelor or prasugrel
- No LAA closure device implanted during procedure
- Procedural complication of LAA closure (e.g., stroke, systemic embolism, bleeding, vascular complication [e.g., groin hematoma >10cm, AV fistula, or pseudoaneurysm), or serious pericardial effusion)
- Planned surgery or invasive procedure within 6±2 weeks of enrollment
Where it is running
- Scripps Health — La Jolla, California, United States (enrolling)
Full record on ClinicalTrials.gov
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