Transcatheter Aortic Valve Intervention-Live Transmission

Medstar Health Research Institute110 enrolled

Overview

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.

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

110

Conditions

Aortic Valve Disorder

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Saint Paul's Hospital

Vancouver, British Columbia, Canada

CardioVasculares Centrum Frankfurt

Frankfurt, Germany

San Raffaele Hospital

Milan, Italy

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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