CryoValve SG Pulmonary Human Heart Valv… | Clinical Trial

Key information

Conditions

Pulmonary Valve Stenosis Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pulmonary Valve Insufficiency Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Pediatric Cardiology Consultants, Phoenix, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echocardiogram

Procedure

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

Primary outcomes

Hemodynamic Performance

Time frame: Most Recent follow-up (average of 3-6 years post implant)

Peak Pulmonary Gradient Mean Pulmonary Gradient
Hemodynamic Performance

Time frame: Most Recent Follow-up (average of 4 to 6 years post implant)

Pulmonary Insufficiency Grade
Safety Assessment

Time frame: Since Implant of the Valve to a Maximum of 13.0 years
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

Sponsors and collaborators

Lead sponsor

CryoLife, Inc.

Industry

Registry information

Acronym: SGPV

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Mar 25, 2010
Registry last updated: Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed