Transcatheter Aortic Valve Intervention-Live Transmission

Aortic Valve Disorder Clinical Trial

— VERITAS  

Official title:

Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353287
• Other study ID #: VERITAS
• Status: Completed
• Phase: N/A
• First received: May 11, 2011
• Last updated: July 30, 2013
• Start date: May 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Aortic Valve Disorder
• Heart Defects, Congenital
• Heart Valve Diseases

Locations

Country	Name	City	State
Canada	Saint Paul's Hospital	Vancouver	British Columbia
Germany	CardioVasculares Centrum Frankfurt	Frankfurt
Italy	San Raffaele Hospital	Milan
Switzerland	Bern University Hospital	Bern
United Kingdom	Guys and St Thomas' Hospital	London
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Research Institute	Food and Drug Administration (FDA)

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major complication defined as in hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, and the need for a pacemaker.		Baseline	Yes