CryoValve SG Pulmonary Human Heart Valve Post Clearance Study (SGPV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CryoLife, Inc.
ClinicalTrials.gov Identifier:
NCT01092442
First received: March 23, 2010
Last updated: December 8, 2015
Last verified: December 2015

March 23, 2010
December 8, 2015
January 2010
December 2014   (final data collection date for primary outcome measure)
  • Hemodynamic Performance [ Time Frame: Most Recent follow-up (average of 3-6 years post implant) ] [ Designated as safety issue: No ]
    Peak Pulmonary Gradient Mean Pulmonary Gradient
  • Hemodynamic Performance [ Time Frame: Most Recent Follow-up (average of 4 to 6 years post implant) ] [ Designated as safety issue: No ]
    Pulmonary Insufficiency Grade
  • Safety Assessment [ Time Frame: Since Implant of the Valve to a Maximum of 13.0 years ] [ Designated as safety issue: Yes ]

    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: Yearly after Implant ] [ Designated as safety issue: No ]
    Peak Pulmonary Gradient Mean Pulmonary Gradient Pulmonary Insufficiency Grade
  • Safety Assessment [ Time Frame: Since Implant of the Valve ] [ Designated as safety issue: Yes ]

    Evaluation of the following adverse events

    • Mortality (all cause and valve-related)
    • Reoperation/reintervention
    • Explant
    • Endocarditis (all and valvular)
    • 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 (all and major)
    • Bleeding (all and major)
    • Hemolysis
    • Calcification
    • Conduit failure
Complete list of historical versions of study NCT01092442 on ClinicalTrials.gov Archive Site
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CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Consecutive patients who have had a CryoValve SG Pulmonary Human Heart Valve implanted in the pulmonary position for right ventricular outflow tract (RVOT) reconstruction or as part of the Ross procedure at selected institutions.
  • Pulmonary Valve Stenosis
  • Pulmonary Valve Insufficiency
  • Aortic Valve Stenosis
  • Aortic Valve Insufficiency
Procedure: Echocardiogram
Patients will have a yearly echocardiogram after enrollment in the study.
  • Retrospective Patients
    Retrospective Patients: The patient group who had the CryoValve SG Pulmonary Human Heart Valve implanted prior to the February 2008 clearance of the valve.
    Intervention: Procedure: Echocardiogram
  • Prospective Patients
    Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
    Intervention: Procedure: Echocardiogram

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2014
December 2014   (final data collection date for primary outcome measure)

• 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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01092442
CSG801.002-M
No
Not Provided
Not Provided
CryoLife, Inc.
CryoLife, Inc.
Not Provided
Study Director: Scott B Capps, MS CryoLife, Inc.
CryoLife, Inc.
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP