CryoValve® SG Aortic Human Heart Valve Combination Study

Aortic Valve Stenosis Clinical Trial

— SGAV  

Official title:

CryoValve® SG Aortic Human Heart Valve Combination Retrospective/Prospective, Multi-Center, Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236469
• Other study ID #: SGA0903.000 - C(09/09)
• Status: Completed
• Phase: N/A
• First received: October 1, 2010
• Last updated: August 17, 2015
• Start date: June 2010
• Est. completion date: February 2012

Study information

• Verified date: August 2015
• Source: CryoLife, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 27 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Intervention

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.

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	The Children's Hsopital	Aurora	Colorado
United States	Indiana University	Indianapolis	Indiana
United States	The Children's Mercy Hospital	Kansas City	Missouri
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Arizona Pediatric Cardiology Consultants	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Rady Children's Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
CryoLife, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. Erratum in: Circulation. 2007 Apr 17;115(15):e409. Circulation. 2010 Jun 15;121(23):e443. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	Yes