Aortic Valve Stenosis Clinical Trial
— SGPVOfficial title:
CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
Verified date | December 2015 |
Source | CryoLife, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
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. |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
CryoLife, Inc. |
United States,
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
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 |
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