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Aortic Valve Replacement With Trifecta(TM)

NCT00475709 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1022

Last updated 2019-02-19

Study results available
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Summary

To confirm the clinical safety and effectiveness of the Trifecta valve.

Conditions

  • Aortic Valve Insufficiency
  • Regurgitation, Aortic Valve
  • Aortic Valve Incompetence
  • Aortic Valve Stenosis

Interventions

DEVICE

Trifecta Aortic Heart Valve

Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Hartzell Schaff, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-07-31
Completion
2012-01-31

Countries

  • United States

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 NCT00475709 on ClinicalTrials.gov