466 Studies Now Enrolling
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).
ALIGN AR-HDE: JenaValve Pericardial TAVR Aortic Regurgitation Study
| Sponsor: | JenaValve Technology, Inc. |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAQ5551 |
| U.S. Govt. ID: | NCT02732704 |
| Contact: | Sarah Borden: 212-342-5129 / sb1097@cumc.columbia.edu |
Additional Study Information:
The objective of this study is to evaluate the safety and probable benefit of the transfemoral JenaValve Pericardial TAVR System in a patient population with symptomatic severe aortic regurgitation (also called aortic insufficiency or a leaky valve) requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).
This study is closed
Do You Qualify?
| 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 |