Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Disorder
- Sponsor
- Medstar Health Research Institute
- Enrollment
- 110
- Locations
- 6
- Primary Endpoint
- Major complication defined as in hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, and the need for a pacemaker.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Major complication defined as in hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, and the need for a pacemaker.
Time Frame: Baseline