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 |