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Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

NCT00630916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2011-09-22

Study results available
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Summary

This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Conditions

  • Heart Valve Diseases

Interventions

DEVICE

Mitroflow Aortic Heart Valve

Replacement of the native aortic valve or a previously implanted prosthetic aortic valve

Sponsors & Collaborators

  • Sorin Group USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Mary Onxley · Sorin Group USA, Inc.

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
2003-11-30
Primary Completion
2005-12-31
Completion
2007-12-31

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 NCT00630916 on ClinicalTrials.gov