Early Feasibility Study of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System (TIARA-I)
| Sponsor: |
Neovasc Inc. |
| Enrolling: |
Male and Female Patients |
| IRB Number: |
AAAO5703 |
| U.S. Govt. ID: |
NCT02276547 |
| Contact: |
Martin Leon: 212-342-3617 / ml2398@columbia.edu |
The purpose of this study is to find out if the mitral valve can be safely replaced using a procedure that issimpler than the open-heart procedure being used today and may be safer for patients who are at ahigher risk from conventional open-heart surgery. The device being studied would be implanted without the need for an open-heart procedure and without the need for a heart and lung machine. This is thefirst research study for this device that will be carried out in a small number of subjects. This study is being done to learn initial information about the basic safety and function of this device.
This study is closed
Investigator
Martin Leon, MD
| Are you at high surgical risk for open mitral valve surgery? |
Yes |
No |