CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CryoLife, Inc.
- Enrollment
- 140
- Locations
- 8
- Primary Endpoint
- Safety Assessment
Study Overview
Brief Summary
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Hemodynamic Performance
Time Frame: Most Recent Follow-up (average of 4 to 6 years post implant)
Pulmonary Insufficiency Grade
Secondary Outcomes
No secondary outcomes reported