Transcatheter Aortic Valve Intervention-Live Transmission

Completed

• Conditions: Aortic Valve Disorder

• Registration Number: NCT01353287
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

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.

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-11
• Study First Submitted QC: 2011-05-12
• Study First Posted: 2011-05-13
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-30
• Last Update Posted: 2013-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major complication defined as in hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, and the need for a pacemaker.	Baseline

Trial Locations

Locations (6)

CardioVasculares Centrum Frankfurt; 🇩🇪 Frankfurt, Germany

Bern University Hospital; 🇨🇭 Bern, Switzerland

San Raffaele Hospital; 🇮🇹 Milan, Italy

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Saint Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Guys and St Thomas' Hospital; 🇬🇧 London, United Kingdom