Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)

MedStar Health

Status: Completed

Conditions: Aortic Valve Disorder

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01353287

VERITAS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

110 participants in 2 patient groups

TAVI live case or video-taped transmission

TAVI without transmission