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The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
The clinical investigation is a multi-center, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implanted with Biocor or Biocor Supra Valves | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biocor and Biocor Supra valves | Device | Replacement for a diseased, damaged, malformed aortic or mitral heart valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number of participants with Adverse Events | 5 Years |
| Characterize Patient NYHA Functional Classification Status | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256. | 5 year |
| Characterize the Hemodynamic Performance of the Valve | Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve. | 5 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Urban Lonn, MD, PhD | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Hospital/Scripps Clinic | La Jolla | California | 92103 | United States | ||
| USC University Hospital, Department of Cardiothoracic Surgery |
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| ID | Title | Description |
|---|---|---|
| FG000 | Implanted With Biocor or Biocor Supra Valves | Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Los Angeles |
| California |
| 90033 |
| United States |
| The Heart Group, PC | Evansville | Indiana | 47710 | United States |
| Indiana Heart Hospital | Indianapolis | Indiana | 46240 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| HealthEast St. Joseph Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | United States |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37660 | United States |
| Saint Thomas Hospital | Nashville | Tennessee | 37205 | United States |
| Sentara Norfolk General Hospital/Sentara Heart Hospital | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Implanted With Biocor or Biocor Supra Valves | Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Number of Participants With Adverse Events | Number of participants with Adverse Events | Posted | Number | participants | 5 Years |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Characterize Patient NYHA Functional Classification Status | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256. | Number of participants that completed the visit and assessment | Posted | Number | participants | 5 year |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Characterize the Hemodynamic Performance of the Valve | Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve. | Number of participants that completed the visit and assessment | Posted | Mean | Standard Deviation | mmHg | 5 Year |
|
|
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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 | Implanted With Biocor or Biocor Supra Valves | Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve | 91 | 297 | 0 | 297 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Bleed | Vascular disorders |
| |||
| Minor Bleed | Vascular disorders |
| |||
| Embolism | Nervous system disorders |
| |||
| Endocarditis | Cardiac disorders |
| |||
| Reoperation-Explant | Surgical and medical procedures |
| |||
| Structural Deterioration | Cardiac disorders |
| |||
| Thrombosis | Cardiac disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Manager | St Jude Medical | 6517566803 | jjohnson101@sjm.com |
| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| D001024 | Aortic Valve Stenosis |
| D008944 | Mitral Valve Insufficiency |
| D008946 | Mitral Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| Title | Measurements |
|---|---|
|
| Embolism |
|
| Endocarditis |
|
| Reoperation-explant |
|
| Structural Deterioration |
|
| Thrombosis |
|
|
|