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Transcatheter Aortic Valve Intervention-Live Transmission

NCT ID: NCT01353287

Last Updated: 2013-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Aortic Valve Disorder

Keywords

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Transcatheter Aortic Valve Intervention (TAVI) Live case transmission

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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TAVI live case or video-taped transmission

No interventions assigned to this group

TAVI without transmission

No interventions assigned to this group

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Food and Drug Administration (FDA)

FED

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Hospital Center, Washington, DC

Locations

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MedStar Washington Hospital Center

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

Site Status

Saint Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

CardioVasculares Centrum Frankfurt

Frankfurt, , Germany

Site Status

San Raffaele Hospital

Milan, , Italy

Site Status

Bern University Hospital

Bern, , Switzerland

Site Status

Guys and St Thomas' Hospital

London, , United Kingdom

Site Status

Countries

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United States Canada Germany Italy Switzerland United Kingdom

Other Identifiers

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VERITAS

Identifier Type: -

Identifier Source: org_study_id