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ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm

NCT00657826 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-06-22

No results posted yet for this study

Summary

The initial clinical investigation titled "ATS 3f(r) Aortic Bioprosthesis Model 1000 Study," was a prospective, non-randomized, multi-center study designed to evaluate the the safety and effectiveness obtained from 800 patient years using a common clinical protocol. Twenty-three (23) sites internationally and in the United States combined enrolled 405 patients. The objective of the study was to evaluate the safety and effectiveness of the ATS 3f(r) Aortic Bioprosthesis Model 1000 equine pericardial prosthesis in a a patient population undergoing isolated aortic valve replacement of his / her native aortic valve, or replacement of a failed prosthesis with or without concomitant procedures.

Addendum: After receiving PMA approval in October of 2008 of the 21mm-29mm sizes, this IDE was expanded to comply with the conditions set forth in the approval notice. Study Protocol S2001 Rev. E is a continuation of the original protocol, but is only enrolling subjects who require a 19mm ATS 3f(r) Aortic Bioprosthesis, Model 1000 and is described as "A multi-center, non-randomized trial, designed to obtain 800 patient years. Each enrolled patient will be followed for a minimum one year and annually thereafter until size 19mm product approval or study cessation. Preoperative, discharge or 30 days (which ever comes last), 3-6 month, and annual follow-up data are required.

Conditions

  • Heart Valve Diseases

Interventions

DEVICE

ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm

Isolated aortic valve replacement with a size 19mm valve

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Ryan Palmer · Medtronic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00657826 on ClinicalTrials.gov