Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

Stopped early · Not applicable

Conditions studied: Aortic Valve Disease

In brief

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.

Key facts

Study ID

NCT00705913

Run by

Sorin Group USA, Inc.

People needed

368

Starts

2008-06-01

Expected to finish

2011-09-01

Last updated by the study team

2012-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• 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 — The 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
• St.Boniface General Hospital — Winnipeg, Manitoba, Canada
• Hopital Laval — Sainte-Foy, Quebec, Canada

Full record on ClinicalTrials.gov

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