CryoValve® SG Aortic Human Heart Valve Combination Study

Completed

• Conditions: Aortic Valve Insufficiency; Aortic Valve Stenosis
• Interventions: Procedure: Echocardiogram

• Registration Number: NCT01236469
• Lead Sponsor: CryoLife, Inc.

Brief Summary

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.

Detailed Description

The CryoValve SG aortic human heart valve is recovered from deceased human donors, treated with the SynerGraft® (SG) process,which is designed to reduce the donor cells present on the graft. The valve is then cryopreserved for storage until use. Removing cells from the heart valve has been shown to reduce a component of the immune response after implant compared to a standard allograft valve. However, it is not known how this affects the long-term durability of the valve.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-07
• Primary Completion: 2011-05
• Study Completion: 2012-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective Patients	Echocardiogram	Pediatric (21 years of age or younger) patients who received a CryoValve SG Aortic Valve distributed during the 2000 to 2003 period as an aortic valve replacement.

Primary Outcome Measures

Name	Time	Method
Hemodynamic Performance	From Implant until Study Enrollment (on average, 7 years)	Peak Aortic Gradient (or Peak Velocity), Mean Aortic Gradient, Aortic Insufficiency, Effective Orifice Area
Number of Adverse Events as a Measure of Safety	From Implant until Study Enrollment (on average, 7 years)	Safety parameters will follow the guidelines for reporting morbidity and mortality after cardiac valvular operations as established by The American Association for Thoracic Surgery and The Society of Thoracic Surgeons.; Evaluation of the following adverse events: * Mortality (all cause and valve-related); * Reoperation/reintervention; * Explant; * Endocarditis (all and valvular); * Thrombosis; * Thromboembolism; * Non-structural dysfunction; * Perivalvular leak (all and major); * Bleeding (all and major); * Hemolysis; * Calcification; * Conduit failure

Trial Locations

Locations (9)

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

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

The Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States