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CryoValve® SG Aortic Human Heart Valve Combination Study (SGAV)

This study has suspended participant recruitment.
(Due to limited resources)
Sponsor:
Information provided by (Responsible Party):
CryoLife, Inc.
ClinicalTrials.gov Identifier:
NCT01236469
First received: October 1, 2010
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human Heart Valve used in pediatric patients as an aortic valve replacement.


Condition Intervention
Aortic Valve Stenosis
Aortic Valve Insufficiency
 Procedure: Echocardiogram

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CryoValve® SG Aortic Human Heart Valve Combination Retrospective/Prospective, Multi-Center, Cohort Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CryoLife, Inc.:

Primary Outcome Measures:
  • Hemodynamic Performance [ Time Frame: From Implant until Study Enrollment (on average, 7 years) ] [ Designated as safety issue: No ]
    Peak Aortic Gradient (or Peak Velocity), Mean Aortic Gradient, Aortic Insufficiency, Effective Orifice Area

  • Number of Adverse Events as a Measure of Safety [ Time Frame: From Implant until Study Enrollment (on average, 7 years) ] [ Designated as safety issue: Yes ]

    Safety parameters will follow the guidelines for reporting morbidity and mortality after cardiac valvular operations as established by The American Association for Thoracic Surgery and The Society of Thoracic Surgeons.

    Evaluation of the following adverse events:

    • Mortality (all cause and valve-related)
    • Reoperation/reintervention
    • Explant
    • Endocarditis (all and valvular)
    • Thrombosis
    • Thromboembolism
    • Non-structural dysfunction
    • Perivalvular leak (all and major)
    • Bleeding (all and major)
    • Hemolysis
    • Calcification
    • Conduit failure


Estimated Enrollment: 50
Study Start Date: June 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Retrospective Patients
Pediatric (21 years of age or younger) patients who received a CryoValve SG Aortic Valve distributed during the 2000 to 2003 period as an aortic valve replacement.
 Procedure: Echocardiogram
A prospective follow-up Study Echocardiogram will be performed, as applicable, for those subjects who do not have echo data as of January 1, 2009.

Detailed Description:

The CryoValve SG aortic human heart valve is recovered from deceased human donors, treated with the SynerGraft® (SG) 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:   6 Years to 27 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric (21 years of age or younger) patients who received a CryoValve SG Aortic Valve distributed during the 2000 to 2003 period as an aortic valve replacement.

Criteria

Inclusion Criteria:

  • Patients implanted with a CryoValve SGAV as an aortic valve replacement.
  • Patients who were ≤ 21 years of age at the time of implant.

Exclusion Criteria:

  • Patients in whom the CryoValve SGAV was used as a patch or a non-valved conduit.
  • Patients implanted with a CryoValve SGAV as a pulmonary valve replacement.
  • Patients that were ≥ 22 years of age at the time of implant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236469

Locations
United States, Arizona
Arizona Pediatric Cardiology Consultants
Phoenix, Arizona, United States, 85006
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Colorado
The Children's Hsopital
Aurora, Colorado, United States, 80045
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
CryoLife, Inc.
Investigators
Study Director: Scott B Capps, MS CryoLife, Inc.
  More Information

Publications:
American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; Bonow RO, Carabello BA, Kanu C, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): developed in collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Circulation. 2006 Aug 1;114(5):e84-231. Review. No abstract available. Erratum in: Circulation. 2010 Jun 15;121(23):e443. Circulation. 2007 Apr 17;115(15):e409.

Responsible Party: CryoLife, Inc.
ClinicalTrials.gov Identifier: NCT01236469     History of Changes
Other Study ID Numbers: SGA0903.000 - C(09/09)
Study First Received: October 1, 2010
Last Updated: March 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by CryoLife, Inc.:
Aortic Valve

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on May 19, 2013