Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

Not Applicable

Terminated

• Conditions: Aortic Valve Disease

• Registration Number: NCT00705913
• Lead Sponsor: Sorin Group USA, Inc.

Brief 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.

Detailed Description

Comparisons of valve types are often made according to labeled valve sizes. There is growing evidence that in the majority of cases the actual sizer and valve dimensions vary from the labeled diameters, which may not be related to any hemodynamically meaningful dimension. The disagreement between the true valve dimensions and the labeled valve size may render comparisons based on labeled size meaningless

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-27
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2011-11
• Last Update Submitted: 2012-01-06
• Last Update Posted: 2012-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

• Patients who are indicated for implant with a bioprosthetic valve in the aortic position according to the current practice for valve selection at the center.

Exclusion Criteria

• Less than 18 years of age
• Emergency Surgery
• Pre-existing valve prothesis in the aortic position
• Aortic root replacements or enlargements
• Active endocarditis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus	6 months

Secondary Outcome Measures

Name	Time	Method
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate higher ratio of EOA to the aortic annulus area.	6 months

Trial Locations

Locations (12)

Sharp Memorial Hospital; 🇺🇸 San Diego, California, United States

Pepin Heart Hospital; 🇺🇸 Tampa, Florida, United States

St. Luke's Medical Center; 🇺🇸 Kansas City, Kansas, United States

Peninsula Regional Medical Center; 🇺🇸 Salisbury, Maryland, United States

St. John's Medical Research Inst.; 🇺🇸 Springfield, Missouri, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

The Heart Hospital Baylor Plano; 🇺🇸 Plano, Texas, United States

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