Optimize PRO TAVR Post Market Study
Sponsor: |
Medtronic, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAS6910 |
U.S. Govt. ID: |
NCT04091048 |
Contact: |
Kate Dalton: (347) 514-3366 / keb2114@cumc.columbia.edu |
The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved in the United States by the Food and Drug Administration (FDA) in 2014, the procedure and valve iterations have become increasingly efficient with reducing complications. The EvolutTM PRO valves outer pericardial wrap has shown to enhance annular sealing resulting in a decrease in paravalvular leak. There is also a growing shift towards optimizing the TAVR care pathway by protocolizing the pre, peri, and post procedure assessments. This optimization can further increase the efficiency of the procedure and subsequently decrease the length of hospital stay and reduce health care costs.
This study is closed
Investigator
Tamim Nazif, MD
Are you 18 years of age or older? |
Yes |
No |