CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-12-31

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.

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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.

Conditions

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Pulmonary Valve Stenosis Pulmonary Valve Insufficiency Aortic Valve Stenosis Aortic Valve Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Retrospective Patients

Retrospective Patients: The patient group who had the CryoValve SG Pulmonary Human Heart Valve implanted prior to the February 2008 clearance of the valve.

Echocardiogram

Intervention Type PROCEDURE

Patients will have a yearly echocardiogram after enrollment in the study.

Prospective Patients

Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.

Echocardiogram

Intervention Type PROCEDURE

Patients will have a yearly echocardiogram after enrollment in the study.

Interventions

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Echocardiogram

Patients will have a yearly echocardiogram after enrollment in the study.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

• 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No