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

October 1, 2010
March 7, 2013
June 2010
March 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01236469 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
CryoValve® SG Aortic Human Heart Valve Combination Study
CryoValve® SG Aortic Human Heart Valve Combination Retrospective/Prospective, Multi-Center, Cohort Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Aortic Valve Stenosis
  • Aortic Valve Insufficiency
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.
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.
Intervention: Procedure: Echocardiogram

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
50
June 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
6 Years to 27 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01236469
SGA0903.000 - C(09/09)
No
CryoLife, Inc.
CryoLife, Inc.
Not Provided
Study Director: Scott B Capps, MS CryoLife, Inc.
CryoLife, Inc.
March 2013

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