A Study to Assess Safety and Probable Benefit of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR)
Sponsor: |
JenaValve Technology, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ5551 |
U.S. Govt. ID: |
NCT02732704 |
Contact: |
Kate Dalton: / keb2114@cumc.columbia.edu |
The objective of the study is to evaluate the safety and efficacy of the JenaValve Pericardial TAVR system when treating patients with aortic regurgitation. Aortic Regurgitation is a condition that develops when the heart's aortic valve does close tightly, therefore the blood leaks back into the heart chamber. The JenaValve Pericardial TAVR system will be used to treat this condition and restore proper flow blood. Treatment of aortic regurgitation with the JenaValve provides a controlled valve release and deployment during the entire implantation procedure under beating heart conditions, which enables a correct positioning and re-positioning of the prosthesis into the cusps of the native aortic valve. A maximum of 180 subjects will be enrolled; with up to 15 subjects enrolled in the CT sub- study. A maximum of 30 centers in the United States will participate in the study. The duration of the study is estimated at approximately 72 months total, for the period spanning enrollment (estimated at approximately 12 months) through completion of 5-year follow-up.
Investigator
Susheel Kodali, MD
Has your doctor told you that you have aortic regurgitation, also called aortic insufficiency or a leaky valve? |
Yes |
No |
Do you feel symptoms from your aortic regurgitation, such as increased shortness of breath, fatigue, or ankle swelling? |
Yes |
No |
Are you at higher risk for traditional open heart surgery? |
Yes |
No |
Can you commit to returning annually to CUMC in NYC for the next five years of required research follow up? |
Yes |
No |