CryoValve SG Pulmonary Human Heart Valve Post Clearance Study (SGPV)

CryoLife

Status: Completed

Conditions: Aortic Valve Stenosis; Pulmonary Valve Stenosis; Aortic Valve Insufficiency; Pulmonary Valve Insufficiency

Treatments: Procedure: Echocardiogram

Study type: Observational

Funder types: Industry

Identifiers

NCT01092442

CSG801.002-M

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

140 participants in 2 patient groups

Retrospective Patients

Description:

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

Treatment:

Procedure: Echocardiogram

Prospective Patients

Description:

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

Treatment:

Procedure: Echocardiogram