Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

Completed · Not applicable

Conditions studied: Heart Valve Diseases

In brief

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.

Key facts

Study ID

NCT00630916

Run by

Sorin Group USA, Inc.

People needed

756

Starts

2003-11-01

Expected to finish

2007-12-01

Last updated by the study team

2011-09-22

Who can join

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

You may qualify if…

• The subject is male or female 18 years old or older
• The subject or subject's legal representative is willing to sign the informed consent
• A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve or prosthesis accord gin to the current medical practice for valve selection at the center
• The subject is able to return for all follow-up evaluations for the duration of the study (i.e. geographically stable

You may not qualify if…

• The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position
• The patient requires a double or triple valve replacement
• The patient had a Mitroflow Heart valve during the clinical study but who then had the valve explanted
• The patient has active endocarditis
• The subject is or will be participating in a concomitant research study of an investigational product
• The subject is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
• The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient the patient is pregnant or lactating

Where it is running

• Banner Good Samaritan — Phoenix, Arizona, United States
• The University of Arizona — Tucson, Arizona, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Methodist Hospital — Indianapolis, Indiana, United States
• Heart Center of Indiana — Indianapolis, Indiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• St. Joseph's Medical Center — Towson, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Luke's Hospital — Kansas City, Missouri, United States
• Saint Michael's Med. Center — Newark, New Jersey, United States
• Newark Beth Israel Med Ctr — Newark, New Jersey, United States
• Westchester County Med Ctr — Valhalla, New York, United States
• Providence St. Vincent — Portland, Oregon, United States
• Hershey Medical Center — Hershey, Pennsylvania, United States
• Hospital of the Univ. of PA — Philadelphia, Pennsylvania, United States
• Lankenau Hospital — Wynnewood, Pennsylvania, United States
• Baylor Univ. Medical Center — Dallas, Texas, United States
• Denton Regional Medical — Denton, Texas, United States
• Medical Center of Plano — Plano, Texas, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• Foothills Medical Centre — Calgary, Alberta, Canada
• Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
• Sunnybrook and Women's College Health Sciences Centre — Toronto, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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