Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (NCT02928497) | Clinical Trial Compass
CompletedNot Applicable
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
United States481 participantsStarted 2017-02-06
Plain-language summary
The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* The subject is of legal age to participate in the study per the laws of their respective geography.
* The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease).
* The subject has a calculated CHA2DS2-VASc score of 2 or greater.
* The subject is deemed by two study physicians to be unsuitable for oral anticoagulation.
* The subject is deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant.
* The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
* The subject is able and willing to return for required follow-up visits and examinations.
Exclusion Criteria:
* The subject is unable or unwilling to return for required follow-up visits and examinations.
* The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
* The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).
* The subject had a prior stroke (of …
What they're measuring
1
Primary 7-Day Device/Procedural Safety Endpoint
Timeframe: 7 days
2
Primary Efficacy Endpoint - time to first event of ischemic stroke or systemic embolism.