IRB Study Number 23-863
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The objective of this study is to collect real-world outcomes data on WATCHMAN FLX™ Pro Device in patients who are implanted with the WATCHMAN FLX Pro device in a commercial clinical setting. This is a 1 year study where patients are to come in for the procedure itself, a 45 day follow up visit, a 6 month follow up visit and a 1 year follow up visit. These visits are to check to see how the device is seated in your heart and to check your medication regiments post procedure.
Inclusion Criteria
Subject is of legal age to participate in the study.
Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device.
Exclusion Criteria
Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
Intracardiac thrombus is present.
The LAA anatomy will not accommodate a Closure Device.
