CryoValve® SG Aortic Human Heart Valve Combination Study

Browse trials for

• Aortic Valve Stenosis 985
• Aortic Valve Insufficiency 162

Keywords

• Aortic Valve

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 50 is below the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.

Lead sponsor

CryoLife, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Study population

Groups and cohorts

• 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

Interventions

• ProcedureEchocardiogram

  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.

Primary outcomes

1. Hemodynamic Performance

   Peak Aortic Gradient (or Peak Velocity), Mean Aortic Gradient, Aortic Insufficiency, Effective Orifice Area

   Time frame: From Implant until Study Enrollment (on average, 7 years)

2. 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

   Time frame: From Implant until Study Enrollment (on average, 7 years)

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. 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. PubMed 16880336 ↗
• 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. PubMed 18374749 ↗
• 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. PubMed 16214512 ↗