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

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis
• Intervention / Treatment: Procedure: Echocardiogram

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.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Arizona Pediatric Cardiology Consultants
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73126
      • Oklahoma University Health and Sciences Center
  • Texas
    • Austin, Texas, United States, 78756
      • Cardiothoracic and Vascular Surgeons and Austin Heart
    • San Antonio, Texas, United States, 78229
      • Methodist Healthcare System of San Antonio
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53201
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic Performance	Peak Pulmonary Gradient Mean Pulmonary Gradient	Most Recent follow-up (average of 3-6 years post implant)
Hemodynamic Performance	Pulmonary Insufficiency Grade	Most Recent Follow-up (average of 4 to 6 years post implant)
Safety Assessment	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	Since Implant of the Valve to a Maximum of 13.0 years

Collaborators and Investigators

• Sponsor: CryoLife, Inc.

Publications and helpful links

General Publications

• Brown JW, Elkins RC, Clarke DR, Tweddell JS, Huddleston CB, Doty JR, Fehrenbacher JW, Takkenberg JJ. Performance of the CryoValve SG human decellularized pulmonary valve in 342 patients relative to the conventional CryoValve at a mean follow-up of four years. J Thorac Cardiovasc Surg. 2010 Feb;139(2):339-48. doi: 10.1016/j.jtcvs.2009.04.065.
• Konuma T, Devaney EJ, Bove EL, Gelehrter S, Hirsch JC, Tavakkol Z, Ohye RG. Performance of CryoValve SG decellularized pulmonary allografts compared with standard cryopreserved allografts. Ann Thorac Surg. 2009 Sep;88(3):849-54; discussion 554-5. doi: 10.1016/j.athoracsur.2009.06.003.
• Hawkins JA, Hillman ND, Lambert LM, Jones J, Di Russo GB, Profaizer T, Fuller TC, Minich LL, Williams RV, Shaddy RE. Immunogenicity of decellularized cryopreserved allografts in pediatric cardiac surgery: comparison with standard cryopreserved allografts. J Thorac Cardiovasc Surg. 2003 Jul;126(1):247-52; discussion 252-3. doi: 10.1016/s0022-5223(03)00116-8.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: March 23, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (ESTIMATE): March 25, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 6, 2016
• Last Update Submitted That Met QC Criteria: August 26, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Pulmonary Valve; Right Ventricular Outflow Tract Reconstruction; Ross Procedure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency; Constriction, Pathologic; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis
• Other Study ID Numbers: CSG801.002-M