CryoValve® SG Aortic Human Heart Valve Combination Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

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.

Echocardiogram

Intervention Type PROCEDURE

A prospective follow-up Study Echocardiogram will be performed, as applicable, for those subjects who do not have echo data as of January 1, 2009.

Interventions

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Echocardiogram

A prospective follow-up Study Echocardiogram will be performed, as applicable, for those subjects who do not have echo data as of January 1, 2009.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No