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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Arizona Pediatric Cardiology Consultants
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • The Children's Hsopital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • C.S. Mott Children's Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • The Children's Mercy Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 27 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic Performance	Peak Aortic Gradient (or Peak Velocity), Mean Aortic Gradient, Aortic Insufficiency, Effective Orifice Area	From Implant until Study Enrollment (on average, 7 years)
Number of Adverse Events as a Measure of Safety	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	From Implant until Study Enrollment (on average, 7 years)

Collaborators and Investigators

• Sponsor: CryoLife, Inc.

Publications and helpful links

General Publications

• Akins CW, Miller DC, Turina MI, Kouchoukos NT, Blackstone EH, Grunkemeier GL, Takkenberg JJ, David TE, Butchart EG, Adams DH, Shahian DM, Hagl S, Mayer JE, Lytle BW; Councils of the American Association for Thoracic Surgery; Society of Thoracic Surgeons; European Assoication for Cardio-Thoracic Surgery; Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg. 2008 Apr;135(4):732-8. doi: 10.1016/j.jtcvs.2007.12.002. No abstract available.
• 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. doi: 10.1161/CIRCULATIONAHA.106.176857. No abstract available. Erratum In: Circulation. 2007 Apr 17;115(15):e409. Circulation. 2010 Jun 15;121(23):e443.
• Zehr KJ, Yagubyan M, Connolly HM, Nelson SM, Schaff HV. Aortic root replacement with a novel decellularized cryopreserved aortic homograft: postoperative immunoreactivity and early results. J Thorac Cardiovasc Surg. 2005 Oct;130(4):1010-5. doi: 10.1016/j.jtcvs.2005.03.044.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: October 1, 2010
• First Submitted That Met QC Criteria: November 5, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Estimate): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 17, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Aortic Valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: SGA0903.000 - C(09/09)