CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

Aortic Valve Stenosis Clinical Trial

— SGPV  

Official title:

CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092442
• Other study ID #: CSG801.002-M
• Status: Completed
• Phase: N/A
• First received: March 23, 2010
• Last updated: December 8, 2015
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: December 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 collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.

Description:

The CryoValve SG pulmonary human heart valve is recovered from deceased human donors, treated with the SynerGraft® 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: 140
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

• Retrospective Patients

o Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross or RVOT reconstruction between February 2000 and March 2004 who were included in the 510(k) data collection will be identified using the following general criteria to aid in selection of patients who are most likely to provide adequate follow-up data: Patient is alive and the implanted valve is still in place (has not been explanted).

Patient is still under the care of the implanting institution or the implanting surgeon.

Patient was identified as previously providing data for at least one echocardiographic follow-up assessment at a minimum of one year post-implant.

• Additionally, prospective enrolling centers will have the option to enroll retrospective patients. At these centers, all consecutive patients identified from valve implant data at CryoLife, implanted with a CryoValve SG Pulmonary Valve as a valved pulmonary valve prior to Clearance in 2008 will be targeted for inclusion in the retrospective patient data collection.

• Prospective Patients

• Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross or RVOT reconstruction after FDA 510(k) clearance in February 2008 at selected institutions.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Constriction, Pathologic
• Pulmonary Valve Insufficiency
• Pulmonary Valve Stenosis
• Respiratory Insufficiency

Intervention

Procedure:
• Echocardiogram
Patients will have a yearly echocardiogram after enrollment in the study.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Cardiothoracic and Vascular Surgeons and Austin Heart	Austin	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Oklahoma University Health and Sciences Center	Oklahoma City	Oklahoma
United States	Arizona Pediatric Cardiology Consultants	Phoenix	Arizona
United States	Methodist Healthcare System of San Antonio	San Antonio	Texas
United States	Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
CryoLife, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Brown JW, Elkins RC, Clarke DR, Tweddell JS, Huddleston CB, Doty JR, Fehrenbacher JW, Takkenberg JJ. Performance of the CryoValve SG human decellularized pulmonary valve in 342 patients relative to the conventional CryoValve at a mean follow-up of four years. J Thorac Cardiovasc Surg. 2010 Feb;139(2):339-48. doi: 10.1016/j.jtcvs.2009.04.065. — View Citation

Hawkins JA, Hillman ND, Lambert LM, Jones J, Di Russo GB, Profaizer T, Fuller TC, Minich LL, Williams RV, Shaddy RE. Immunogenicity of decellularized cryopreserved allografts in pediatric cardiac surgery: comparison with standard cryopreserved allografts. J Thorac Cardiovasc Surg. 2003 Jul;126(1):247-52; discussion 252-3. — View Citation

Konuma T, Devaney EJ, Bove EL, Gelehrter S, Hirsch JC, Tavakkol Z, Ohye RG. Performance of CryoValve SG decellularized pulmonary allografts compared with standard cryopreserved allografts. Ann Thorac Surg. 2009 Sep;88(3):849-54; discussion 554-5. doi: 10.1016/j.athoracsur.2009.06.003. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic Performance	Peak Pulmonary Gradient Mean Pulmonary Gradient	Most Recent follow-up (average of 3-6 years post implant)	No
Primary	Hemodynamic Performance	Pulmonary Insufficiency Grade	Most Recent Follow-up (average of 4 to 6 years post implant)	No
Primary	Safety Assessment	Evaluation of the following adverse events; Mortality (all cause and valve-related); Reoperation/reintervention; Explant; Endocarditis; Structural valve deterioration (defined as >40 mmHg peak pulmonary gradient or >30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency); Thrombosis; Thromboembolism (pulmonary embolism); Non-structural dysfunction; Perivalvular leak; Bleeding; Hemolysis; Calcification	Since Implant of the Valve to a Maximum of 13.0 years	Yes