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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01116037
Other study ID # S2008 Rev. D
Secondary ID
Status Terminated
Phase N/A
First received April 8, 2010
Last updated December 15, 2015
Start date September 2009
Est. completion date November 2015

Study information

Verified date December 2015
Source Medtronic Cardiovascular
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.


Description:

A multi-center non-randomized trial designed to obtain 606 patient years. Each enrolled patient will be followed for a minimum of six (6) years. Preoperative, discharge or 30 days (whichever comes last), 3-6 month, and annual follow-up data are required.


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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
ATS 3f Aortic Bioprosthesis
Equine Pericardial Bioprosthesis for replacement of diseased valve

Locations

Country Name City State
Canada McGill University Health Center Montreal Quebec
United States Baylor University Dallas Texas
United States Columbia University New York New York
United States Cardiac Surgery Clinical Research Center, Inc. Oak Lawn Illinois
United States Univ of Pennsylvania Medical Center Philadelphia Pennsylvania
United States Main Line Health Heart Center Wynnewood Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary efficacy goal is to assess the regurgitation rates Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval. Six Years Yes
Secondary Hemodynamic functional data Hemodynamic functional data Six Years No
Secondary Safety Analysis will be based on the occurence of cardiovascular complications. Safety Analysis will be based on one the occurence of cardiovascular complications. Events will be classified as device-related and non-device related. Six Years Yes
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