Transcatheter Aortic Valve Intervention-Live Transmission
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/16/2013 |
| Start Date: | May 2011 |
| Contact: | Rebecca Torguson, MPH |
| Email: | rebecca.torguson@medstar.net |
| Phone: | 202-877-2194 |
Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)Study
The primary objective of this clinical trial is to evaluate safety of patients who underwent
Transcatheter Aortic Valve Intervention (TAVI) during a live case or video-taped
transmission as compared to those without procedure transmission.
A series of sites from outside the US, where the Edwards-Sapien and CoreValve devices are
approved for commercial sale and implantation, will be recruited to retrospectively identify
and extract in-hospital data of a patient who underwent TAVI during a live or video-taped
procedure and a matched patient who underwent TAVI without transmission of the procedure.
Cases Inclusion Criteria:
- Subjects > 18 years of age, male or female
- Subject had live case or video-taped transmission of TAVI procedure with:
Edwards-Sapien transfemoral approach, Edwards-Sapien transapical approach, or CoreValve
transfemoral approach
Controls Inclusion Criteria:
- Subjects > 18 years of age, male or female
- Subject underwent TAVI without procedure transmission and had:
Edwards-Sapien transfemoral approach, Edwards-Sapien transapical approach, or CoreValve
transfemoral approach
- Subjects will be matched to Cases upon the following:
- STS SCORE +/- 2points
- Date of TAVI procedure +/- 4weeks
- The first attending for the TAVI procedure
- Access site for TAVI
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