IRB Study Number 21 - 1031
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
To collect real world clinical outcomes data for patients who are implanted with the WATCHMAN FLX device in a commercial clinical setting.
Atrial fibrillation (AF) is one of the most common abnormal rhythm disturbances and affects approximately 5.5 million people worldwide, including 10% of people older than 75 years. The most debilitating consequence of AF is formation of blood clots from stagnant blood flow leading to thromboembolisms and stroke.
The Watchman device was created by Boston Scientific for the purpose of sealing off the Left Atrial Appendage. The Left Atrium is a pocket on the heart where blood gathers and forms into blood clots. The device allows for blood to pass into and out of the Left Atrial Appendage while also giving protection from blood clots. This device has been shown to provide an alternative to oral anticoagulation therapy.
The WATCHMAN FLX Real World Evidence registry is designed to collect real world clinical data including outcomes for patients who are being implanted with the WATCHMAN FLX device in a commercial clinical setting.
The registry will collect both short and long-term data on a large group of patients post FDA approval.
Inclusion Criteria
Patient will receive a Watchman Device.
