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Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

NCT00705913 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2012-01-09

No results posted yet for this study

Summary

The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.

Conditions

  • Aortic Valve Disease

Interventions

DEVICE

Mitroflow Aortic Pericardial Heart Valve (CarboMedics)

Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Pericardial valve as compared to the Edwards Magna valve

DEVICE

Carpentier-Edwards Magna Tissue Valve

Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve

Sponsors & Collaborators

  • Sorin Group USA, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

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 NCT00705913 on ClinicalTrials.gov