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The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiogram | Procedure | Patients will have a yearly echocardiogram after enrollment in the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| Since Implant of the Valve to a Maximum of 13.0 years |
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• 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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Scott B Capps, MS | CryoLife, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pediatric Cardiology Consultants | Phoenix | Arizona | 85006 | United States | ||
| Indiana University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20106397 | Background | 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. | |
| 19699910 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Retrospective Patients | Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve. |
| FG001 | Prospective Patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Indianapolis |
| Indiana |
| 46202 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Oklahoma University Health and Sciences Center | Oklahoma City | Oklahoma | 73126 | United States |
| Cardiothoracic and Vascular Surgeons and Austin Heart | Austin | Texas | 78756 | United States |
| Methodist Healthcare System of San Antonio | San Antonio | Texas | 78229 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
| 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. |
| 12878962 | 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. |
Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Retrospective Patients | Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemodynamic Performance | Peak Pulmonary Gradient Mean Pulmonary Gradient | The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group. | Posted | Mean | Standard Deviation | mmHg | Most Recent follow-up (average of 3-6 years post implant) |
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| Primary | Hemodynamic Performance | Pulmonary Insufficiency Grade | The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group. | Posted | Number | participants | Most Recent Follow-up (average of 4 to 6 years post implant) |
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| Primary | Safety Assessment | Evaluation of the following adverse events
| Posted | Number | percentage of patients | Since Implant of the Valve to a Maximum of 13.0 years |
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Since Implant of the Valve to a Maximum of 13 years
Other Adverse Events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ross Patients | Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure | 5 | 68 | 0 | 0 | ||
| EG001 | RVOT Reconstruction Patients | Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures | 11 | 72 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mortality | Cardiac disorders |
| |||
| Explant | Cardiac disorders |
| |||
| Reoperation/Reintervention | Cardiac disorders |
| |||
| Endocarditis | Cardiac disorders |
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| Bleeding | Cardiac disorders |
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The PI can not publish any results or data arising from the study except with the institution's approval and sponsor's written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott B. Capps, MS | CryoLife, Inc. | 800-438-8285 | clinicaltrialregistration@cryolife.com |
| ID | Term |
|---|---|
| D011666 | Pulmonary Valve Stenosis |
| D011665 | Pulmonary Valve Insufficiency |
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D000082862 | Aortic Valve Disease |
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| >=65 years |
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| Male |
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| Mean Pulmonary Gradient |
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