SGAV: CryoValve® SG Aortic Human Heart Valve Combination Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Hemodynamic Performance [From Implant until Study Enrollment (on average, 7 years)]
Peak Aortic Gradient (or Peak Velocity), Mean Aortic Gradient, Aortic Insufficiency, Effective Orifice Area
- Number of Adverse Events as a Measure of Safety [From Implant until Study Enrollment (on average, 7 years)]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients implanted with a CryoValve SGAV as an aortic valve replacement.
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Patients who were ≤ 21 years of age at the time of implant.
Exclusion Criteria:
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Patients in whom the CryoValve SGAV was used as a patch or a non-valved conduit.
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Patients implanted with a CryoValve SGAV as a pulmonary valve replacement.
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Patients that were ≥ 22 years of age at the time of implant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Pediatric Cardiology Consultants | Phoenix | Arizona | United States | 85006 |
| 2 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 3 | Rady Children's Hospital | San Diego | California | United States | 92123 |
| 4 | The Children's Hsopital | Aurora | Colorado | United States | 80045 |
| 5 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 6 | C.S. Mott Children's Hospital | Ann Arbor | Michigan | United States | 48109 |
| 7 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 8 | The Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 9 | 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.
Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- 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.
- SGA0903.000 - C(09/09)