CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

Completed

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

• Registration Number: NCT01092442
• Lead Sponsor: CryoLife, Inc.

Brief Summary

The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.

Detailed Description

The CryoValve SG pulmonary human heart valve is recovered from deceased human donors, treated with the SynerGraft® 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: 2010-01
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2015-11-02
• Results First Submitted QC: 2015-11-02
• Results First Posted: 2015-12-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Patients	Echocardiogram	Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
Retrospective Patients	Echocardiogram	Retrospective Patients: The patient group who had the CryoValve SG Pulmonary Human Heart Valve implanted prior to the February 2008 clearance of the valve.

Primary Outcome Measures

Name	Time	Method
Safety Assessment	Since Implant of the Valve to a Maximum of 13.0 years	Evaluation of the following adverse events; * Mortality (all cause and valve-related); * Reoperation/reintervention; * Explant; * Endocarditis; * Structural valve deterioration (defined as \>40 mmHg peak pulmonary gradient or \>30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency); * Thrombosis; * Thromboembolism (pulmonary embolism); * Non-structural dysfunction; * Perivalvular leak; * Bleeding; * Hemolysis; * Calcification
Hemodynamic Performance	Most Recent Follow-up (average of 4 to 6 years post implant)	Pulmonary Insufficiency Grade

Trial Locations

Locations (8)

Washington University; 🇺🇸 St. Louis, Missouri, United States

Arizona Pediatric Cardiology Consultants; 🇺🇸 Phoenix, Arizona, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

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

Cardiothoracic and Vascular Surgeons and Austin Heart; 🇺🇸 Austin, Texas, United States

Methodist Healthcare System of San Antonio; 🇺🇸 San Antonio, Texas, United States

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States