CryoValve® SG Aortic Human Heart Valve Combination Study

Completed

Conditions studied: Aortic Valve Stenosis, Aortic Valve Insufficiency

In brief

The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human Heart Valve used in pediatric patients as an aortic valve replacement.

Key facts

Study ID

NCT01236469

Run by

CryoLife, Inc.

People needed

50

Starts

2010-06-01

Expected to finish

2012-02-01

Last updated by the study team

2015-08-19

Who can join

Age: 6 and older, up to 27. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients implanted with a CryoValve SGAV as an aortic valve replacement.
• Patients who were ≤ 21 years of age at the time of implant.

You may not qualify if…

• Patients in whom the CryoValve SGAV was used as a patch or a non-valved conduit.
• Patients implanted with a CryoValve SGAV as a pulmonary valve replacement.
• Patients that were ≥ 22 years of age at the time of implant.

Where it is running

• Arizona Pediatric Cardiology Consultants — Phoenix, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Rady Children's Hospital — San Diego, California, United States
• The Children's Hsopital — Aurora, Colorado, United States
• Indiana University — Indianapolis, Indiana, United States
• C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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