CryoValve® SG Aortic Human Heart Valve Combination Study (SGAV)

CryoLife

Status: Completed

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Treatments: Procedure: Echocardiogram

Study type: Observational

Funder types: Industry

Identifiers

NCT01236469

SGA0903.000 - C(09/09)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 6 to 27 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Retrospective Patients

Description:

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.

Treatment:

Procedure: Echocardiogram