CryoValve® SG Aortic Human Heart Valve Combination Study

NCT01236469 | Completed

• 1 other identifier: SGA0903.000 - C(09/09)
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 9

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Keywords

Aortic Valve

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

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

Echocardiogram PROCEDURE

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

Eligibility Criteria

• Age: 6 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Patients implanted with a CryoValve SGAV as an aortic valve replacement.
• Patients who were ≤ 21 years of age at the time of implant.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CryoLife, Inc.: lead

Study Sites (9)

Arizona Pediatric Cardiology Consultants

Phoenix, Arizona, 85006, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

The Children's Hsopital

Aurora, Colorado, 80045, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (3)

• 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.

  PMID: 16880336 BACKGROUND

• 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.

  PMID: 18374749 BACKGROUND

• 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.

  PMID: 16214512 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Scott B Capps, MS

  CryoLife, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: November 8, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: February 1, 2012
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

US (9)