CryoValve® SG Aortic Human Heart Valve Combination Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

6 year–27 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Pediatric Cardiology Consultants, Phoenix, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Echocardiogram

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.

Primary outcomes

Hemodynamic Performance

Time frame: From Implant until Study Enrollment (on average, 7 years)

Peak Aortic Gradient (or Peak Velocity), Mean Aortic Gradient, Aortic Insufficiency, Effective Orifice Area
Number of Adverse Events as a Measure of Safety

Time frame: From Implant until Study Enrollment (on average, 7 years)
Safety parameters will follow the guidelines for reporting morbidity and mortality after cardiac valvular operations as established by The American Association for Thoracic Surgery and The Society of Thoracic Surgeons.

Evaluation of the following adverse events:
- Mortality (all cause and valve-related)
- Reoperation/reintervention
- Explant
- Endocarditis (all and valvular)
- Thrombosis
- Thromboembolism
- Non-structural dysfunction
- Perivalvular leak (all and major)
- Bleeding (all and major)
- Hemolysis
- Calcification
- Conduit failure

Sponsors and collaborators

Lead sponsor

CryoLife, Inc.

Industry

Registry information

Official study title

CryoValve® SG Aortic Human Heart Valve Combination Retrospective/Prospective, Multi-Center, Cohort Study

Acronym: SGAV

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Nov 8, 2010
Registry last updated: Aug 19, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed