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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
CryoLife, Inc.
ClinicalTrials.gov Identifier:
NCT01092442
First received: March 23, 2010
Last updated: July 22, 2014
Last verified: July 2014
  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: 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


Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated 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 were included in support of the CryoValve SG Pulmonary Human Heart Valve 510(k) data collection. These patients had the CryoValve SG Pulmonary 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 and before January 2010.
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

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 reconstruction or as part of the Ross procedure at selected institutions.

Criteria

Inclusion Criteria:

  • Retrospective Patients

    • Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross or RVOT reconstruction between February 2000 and March 2004.
    • Only patients who previously participated in 510(k) data collection for the CryoValve SG Pulmonary Valve at selected institutions
  • 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 and before January 2010 at selected institutions.

Exclusion Criteria:

• Retrospective Patients

  • Based on 510(k) data collection from 342 patients:
  • Patient is not alive and the implanted valve is not in place (has been explanted).
  • Patient is not under the care of the implanting institution or the implanting surgeon.
  • Patient was identified as not providing data for at least one echocardiographic follow-up assessment at a minimum of one year post-implant.
  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
Last Updated: July 22, 2014
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:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Pulmonary Valve Insufficiency
Pulmonary Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014