Transcatheter Aortic Valve Intervention-Live Transmission

Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01353287

Acronym

VERITAS

Enrollment

110

Registered

2011-05-13

Start date

2011-05-31

Completion date

2013-06-30

Last updated

2013-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disorder

Keywords

Transcatheter Aortic Valve Intervention (TAVI), Live case transmission

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Major complication defined as in hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, and the need for a pacemaker.	Baseline

Countries

Canada, Germany, Italy, Switzerland, United Kingdom, United States

Outcome results