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Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01353287
First Posted: May 13, 2011
Last Update Posted: August 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Medstar Health Research Institute
  Purpose
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.

Condition
Aortic Valve Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)Study

Further study details as provided by Medstar Health Research Institute:

Primary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: May 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
TAVI live case or video-taped transmission
TAVI without 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients, male or female, over 18 years of age who have either undergone live case or video-taped transmission of TAVI procedure (Case), or have undergone the procedure without procedure transmission(Control).
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353287


Locations
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States
Canada, British Columbia
Saint Paul's Hospital
Vancouver, British Columbia, Canada
Germany
CardioVasculares Centrum Frankfurt
Frankfurt, Germany
Italy
San Raffaele Hospital
Milan, Italy
Switzerland
Bern University Hospital
Bern, Switzerland
United Kingdom
Guys and St Thomas' Hospital
London, United Kingdom
Sponsors and Collaborators
Medstar Health Research Institute
Food and Drug Administration (FDA)
Investigators
Principal Investigator: Ron Waksman, MD Washington Hospital Center, Washington, DC
  More Information

Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT01353287     History of Changes
Other Study ID Numbers: VERITAS
First Submitted: May 11, 2011
First Posted: May 13, 2011
Last Update Posted: August 1, 2013
Last Verified: July 2013

Keywords provided by Medstar Health Research Institute:
Transcatheter Aortic Valve Intervention (TAVI)
Live case transmission