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Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve

NCT00329667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 761

Last updated 2019-02-04

No results posted yet for this study

Summary

This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.

Conditions

  • Valvular Heart Disease

Interventions

DEVICE

EPIC

Surgical replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic and/or mitral heart valves

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

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
2003-01-31
Primary Completion
2006-03-31
Completion
2008-09-30

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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 NCT00329667 on ClinicalTrials.gov