Transcatheter Aortic Valve Intervention-Live Transmission

NCT01353287 | Completed DMC

• 1 other identifier: VERITAS
• Study Type: observational
• Target: 110
• Locations: 6 countries
• Sites: 6

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.

Conditions

Aortic Valve Disorder

Keywords

Transcatheter Aortic Valve Intervention (TAVI); Live case transmission

Outcome Measures

Primary Outcomes (1)

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

  Baseline

Study Arms (2)

TAVI live case or video-taped transmission

TAVI without transmission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (6)

MedStar Washington Hospital Center

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

Location

Saint Paul's Hospital

Vancouver, British Columbia, Canada

Location

CardioVasculares Centrum Frankfurt

Frankfurt, Germany

Location

San Raffaele Hospital

Milan, Italy

Location

Bern University Hospital

Bern, Switzerland

Location

Guys and St Thomas' Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ron Waksman, MD

  Washington Hospital Center, Washington, DC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 13, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

DE (1); IT (1); CA (1); US (1); GB (1); CH (1)