Cardiovascular Diseases Clinical Trial
Official title:
A Prospective Randomized Study Comparing the Time to Ambulation and Safety of Using a Closure Device Alone and in Conjunction With a Potassium Ferrate Pad (Statseal) Following Transcatheter Aortic Valve Replacement Via the Femoral Artery
The purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that manual pressure will be held, shorter procedure time and less complications after the procedure.
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