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Trial record 9 of 15 for:    "Pulmonic stenosis"

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
  Purpose
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.

Condition Intervention
Pulmonary Valve Stenosis
Pulmonary Valve Insufficiency
Aortic Valve Stenosis
Aortic Valve Insufficiency
Procedure: Echocardiogram

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

Resource links provided by NLM:


Further study details as provided by CryoLife, Inc.:

Primary Outcome Measures:
  • 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


Enrollment: 140
Study Start Date: January 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: Echocardiogram
Patients will have a yearly echocardiogram after enrollment in the study.
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.
Procedure: Echocardiogram
Patients will have a yearly echocardiogram after enrollment in the study.

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092442

Locations
United States, Arizona
Arizona Pediatric Cardiology Consultants
Phoenix, Arizona, United States, 85006
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Oklahoma
Oklahoma University Health and Sciences Center
Oklahoma City, Oklahoma, United States, 73126
United States, Texas
Cardiothoracic and Vascular Surgeons and Austin Heart
Austin, Texas, United States, 78756
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States, 78229
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
CryoLife, Inc.
Investigators
Study Director: Scott B Capps, MS CryoLife, Inc.
  More Information

Publications:
Responsible Party: CryoLife, Inc.
ClinicalTrials.gov Identifier: NCT01092442     History of Changes
Other Study ID Numbers: CSG801.002-M 
Study First Received: March 23, 2010
Results First Received: November 2, 2015
Last Updated: December 8, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by CryoLife, Inc.:
Pulmonary Valve
Right Ventricular Outflow Tract Reconstruction
Ross Procedure

Additional relevant MeSH terms:
Pulmonary Valve Stenosis
Constriction, Pathologic
Aortic Valve Stenosis
Aortic Valve Insufficiency
Pulmonary Valve Insufficiency
Respiratory Insufficiency
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 27, 2016