CryoValve® SG Aortic Human Heart Valve Combination Study

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT01236469

Acronym / sponsor ID

SGAV / SGA0903.000 - C(09/09)

Conditions

Aortic Valve Stenosis, Aortic Valve Insufficiency

Keywords

Aortic Valve

Study type

Observational

Recruitment status

Completed

Enrolment

50 participants (actual)

Lead sponsor

CryoLife, Inc.Industry (pharma, biotech, devices)

Study start

Jun 2010

Primary completion

May 2011 (actual)

Study completion

Feb 2012 (actual)

First posted

8 Nov 2010 (estimated)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

6 to 27 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Hemodynamic Performance

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

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

2. Number of Adverse Events as a Measure of Safety

   Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
• Background: PubMed 16880336American 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.
• Background: PubMed 18374749Akins 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.
• Background: PubMed 16214512Zehr 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

9 sites in 1 country: see every site and its status.