Skip to main content
OpenTrials
Completed

NCT Number: NCT01353287

Transcatheter Aortic Valve Intervention-Live Transmission

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Valve Disorder Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Paul's Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)Study

Acronym: VERITAS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 13, 2011
Registry last updated
Aug 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.