CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

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

Detailed Description
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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.

Official Title
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CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

Conditions
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Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency, Aortic Valve Stenosis, Aortic Valve Insufficiency

Intervention / Treatment
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* Procedure: Echocardiogram


Participation Criteria
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Eligibility Criteria
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• Retrospective Patients o Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross or RVOT reconstruction between February 2000 and March 2004 who were included in the 510(k) data collection will be identified using the following general criteria to aid in selection of patients who are most likely to provide adequate follow-up data: Patient is alive and the implanted valve is still in place (has not been explanted). Patient is still under the care of the implanting institution or the implanting surgeon. Patient was identified as previously providing data for at least one echocardiographic follow-up assessment at a minimum of one year post-implant. Additionally, prospective enrolling centers will have the option to enroll retrospective patients. At these centers, all consecutive patients identified from valve implant data at CryoLife, implanted with a CryoValve SG Pulmonary Valve as a valved pulmonary valve prior to Clearance in 2008 will be targeted for inclusion in the retrospective patient data collection. • Prospective Patients Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross or RVOT reconstruction after FDA 510(k) clearance in February 2008 at selected institutions.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective Patients<br>Retrospective Patients: The patient group who had the CryoValve SG Pulmonary Human Heart Valve implanted prior to the February 2008 clearance of the valve. | Procedure: Echocardiogram<br>* Patients will have a yearly echocardiogram after enrollment in the study.<br>|
| Prospective Patients<br>Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve. | Procedure: Echocardiogram<br>* Patients will have a yearly echocardiogram after enrollment in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic Performance | Peak Pulmonary Gradient Mean Pulmonary Gradient | Most Recent follow-up (average of 3-6 years post implant) | 
| Hemodynamic Performance | Pulmonary Insufficiency Grade | Most Recent Follow-up (average of 4 to 6 years post implant) | 
| Safety Assessment | 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 | Since Implant of the Valve to a Maximum of 13.0 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Valve, Right Ventricular Outflow Tract Reconstruction, Ross Procedure