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Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)

This study is currently recruiting participants.
Verified January 2013 by Medstar Research Institute
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: January 28, 2013
Last verified: January 2013
History of Changes
  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 ]

Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Primary Completion Date: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353287

Contacts
Contact: Rebecca Torguson, MPH 202-877-2194 rebecca.torguson@medstar.net

Locations
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States
Principal Investigator: Ron Waksman, MD            
Canada, British Columbia
Saint Paul's Hospital Recruiting
Vancouver, British Columbia, Canada
Principal Investigator: John Webb, MD            
Germany
CardioVasculares Centrum Frankfurt Recruiting
Frankfurt, Germany
Principal Investigator: Horst Sievert, MD            
Italy
San Raffaele Hospital Recruiting
Milan, Italy
Principal Investigator: Antonio Colombo, MD            
Switzerland
Bern University Hospital Recruiting
Bern, Switzerland
Principal Investigator: Steffen Gloekler, MD            
United Kingdom
Guys and St Thomas' Hospital Recruiting
London, United Kingdom
Principal Investigator: Martyn Thomas, MD            
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: January 28, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 23, 2013