WATCH TAVR Watchman For Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
Sponsor: |
Boston Scientific |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAR5223 |
U.S. Govt. ID: |
NCT03173534 |
Contact: |
Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu |
This is a multicenter, prospective randomized study to determine the safety and efficacy of the Watchman device in patients with irregular heart beat undergoing a less invasive procedure than open heart surgery called Transcatheter Aortic Valve Replacement (TAVR). In this procedure, an x-ray is used to visualize and guide the Watchman device via a catheter to replace the heart valve. This is done for patients with aortic stenosis (AS) where there is reduced blood flow, pain and fatigue because the blood has to work harder to pump blood due to narrowed valves in the blood vessels. The watchman device is FDA approved for stroke prevention in patients with (AF). The aim is to investigate outcomes of implantation of the watchman device in patients with AF undergoing TAVR.
This study is closed
Investigator
Torsten Vahl, MD
Do you have an irregular heartbeat? |
Yes |
No |
Are you scheduled to undergo Transcatheter Aortic Valve Replacement (TAVR) procedure? |
Yes |
No |
Have you had a stroke or mini stroke in the past 6 months? |
Yes |
No |
Are you actively enrolled in another trial of a cardiovascular device or an investigational drug (PMA and registries excluded)? |
Yes |
No |