Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)

This study has been completed.
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01353287
First received: May 11, 2011
Last updated: July 30, 2013
Last verified: July 2013
  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 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Research Institute
Food and Drug Administration (FDA)
Investigators
Principal Investigator: Ron Waksman, MD Washington Hospital Center, Washington, DC
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01353287     History of Changes
Other Study ID Numbers: VERITAS
Study First Received: May 11, 2011
Last Updated: July 30, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 31, 2014