CryoValve SG Pulmonary Human Heart Valve Post Clearance Study (NCT01092442) | Clinical Trial Compass
CompletedNot Applicable
CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
United States140 participantsStarted 2010-01
Plain-language summary
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
Who can participate
SexALL
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• 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.
What they're measuring
1
Hemodynamic Performance
Timeframe: Most Recent follow-up (average of 3-6 years post implant)
2
Hemodynamic Performance
Timeframe: Most Recent Follow-up (average of 4 to 6 years post implant)
3
Safety Assessment
Timeframe: Since Implant of the Valve to a Maximum of 13.0 years