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ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000

NCT01116024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2018-06-26

Study results available
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Summary

This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic Valve is an equine pericardial stented bioprosthesis.

Conditions

  • Heart Valve Diseases

Interventions

DEVICE

ATS 3f Enable Aortic Bioprosthesis Model 6000

Replacement Aortic Heart Valve

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Eric Vang · 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
2006-05-31
Primary Completion
2010-12-31
Completion
2012-08-31

Countries

  • Austria
  • Germany
  • Poland
  • Switzerland
  • United Kingdom

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 NCT01116024 on ClinicalTrials.gov