- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01353287
Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)
July 30, 2013 updated by: Medstar Health Research Institute
Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)Study
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada
- Saint Paul's Hospital
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Frankfurt, Germany
- CardioVasculäres Centrum Frankfurt
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Milan, Italy
- San Raffaele Hospital
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Bern, Switzerland
- Bern University Hospital
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London, United Kingdom
- Guys and St Thomas' Hospital
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District of Columbia
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Washington, District of Columbia, United States
- MedStar Washington Hospital Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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TAVI live case or video-taped transmission
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TAVI without transmission
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ron Waksman, MD, Washington Hospital Center, Washington, DC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
May 11, 2011
First Submitted That Met QC Criteria
May 12, 2011
First Posted (Estimate)
May 13, 2011
Study Record Updates
Last Update Posted (Estimate)
August 1, 2013
Last Update Submitted That Met QC Criteria
July 30, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Veritas
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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