Trials / Completed
CompletedNCT01092442
CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 140 (actual)
- Sponsor
- CryoLife, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
- Pulmonary Valve Stenosis
- Pulmonary Valve Insufficiency
- Aortic Valve Stenosis
- Aortic Valve Insufficiency
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Echocardiogram | Patients will have a yearly echocardiogram after enrollment in the study. |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2010-03-25
- Last updated
- 2016-10-06
- Results posted
- 2015-12-09
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01092442. Inclusion in this directory is not an endorsement.