CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemodynamic Performance |
6; 12; 8; 3; 6; 18 | — |
| PRIMARY Safety Assessment |
84; 97; 100; 100; 100; 81 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01092442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.