CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

NCT01092442 | Completed Results

• 1 other identifier: CSG801.002-M
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.

Conditions

Pulmonary Valve Stenosis; Pulmonary Valve Insufficiency; Aortic Valve Stenosis; Aortic Valve Insufficiency

Keywords

Pulmonary Valve; Right Ventricular Outflow Tract Reconstruction; Ross Procedure

Outcome Measures

Primary Outcomes (3)

• Hemodynamic Performance

  Peak Pulmonary Gradient Mean Pulmonary Gradient

  Most Recent follow-up (average of 3-6 years post implant)

• Hemodynamic Performance

  Pulmonary Insufficiency Grade

  Most Recent Follow-up (average of 4 to 6 years post implant)

• 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

Study Arms (2)

Retrospective Patients

Retrospective Patients: The patient group who had the CryoValve SG Pulmonary Human Heart Valve implanted prior to the February 2008 clearance of the valve.

Procedure: Echocardiogram

Prospective Patients

Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.

Procedure: Echocardiogram

Interventions

Echocardiogram PROCEDURE

Patients will have a yearly echocardiogram after enrollment in the study.

Prospective Patients; Retrospective Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who have had a CryoValve SG Pulmonary Human Heart Valve implanted in the pulmonary position for right ventricular outflow tract (RVOT) reconstruction or as part of the Ross procedure at selected institutions.

• 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• CryoLife, Inc.: lead

Study Sites (8)

Arizona Pediatric Cardiology Consultants

Phoenix, Arizona, 85006, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Oklahoma University Health and Sciences Center

Oklahoma City, Oklahoma, 73126, United States

Location

Cardiothoracic and Vascular Surgeons and Austin Heart

Austin, Texas, 78756, United States

Location

Methodist Healthcare System of San Antonio

San Antonio, Texas, 78229, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Related 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.

  PMID: 20106397 BACKGROUND

• 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.

  PMID: 19699910 BACKGROUND

• 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. doi: 10.1016/s0022-5223(03)00116-8.

  PMID: 12878962 BACKGROUND

MeSH Terms

Conditions

Pulmonary Valve Stenosis; Pulmonary Valve Insufficiency; Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Scott B. Capps, MS
• Organization: CryoLife, Inc.

clinicaltrialregistration@cryolife.com

800-438-8285

Study Officials

• Scott B Capps, MS

  CryoLife, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 25, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 6, 2016
• Results First Posted: December 9, 2015

Record last verified: 2016-08

Locations

US (8)