The REFLECT Trial - A Randomized Evaluation of the TriGuard HDH Embolic Deflection Device to Reduce the Impact of Cerebral Embolic Lesions after TransCatheter Aortic Valve Implantation
| Sponsor: |
Keystone Heart |
| Enrolling: |
Male and Female Patients |
| IRB Number: |
AAAQ9626 |
| U.S. Govt. ID: |
NCT02536196 |
| Contact: |
Lauren Privitera: 212-342-3488 / lp2183@cumc.columbia.edu |
This is a research study designed to look at the safety and effectiveness of the TriGUARD 3 cerebral embolic protection device in patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of the study is to assess whether the TriGUARD 3 can prevent death, stroke, more subtle signs of brain injury, and/or silent brain injury as measured by a magnetic resonance imaging (MRI) study of the brain.
This study is closed
Investigator
Susheel Kodali, MD
| Are you 18 years or older |
Yes |
No |
| Is your physician planning an aortic valve procedure in the future |
Yes |
No |