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To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifecta Valve Group | Experimental | Subjects implanted with a Trifecta valve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifecta valve | Device | surgical replacement of aortic valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late Adverse Event Incidence | Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100] | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Northwestern Hospital Cardiac Surgical Associates | Minneapolis | Minnesota | 55407 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Trifecta Valve Group | Subjects implanted with a Trifecta valve. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trifecta Valve Group | Subjects implanted with a Trifecta valve. |
| 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 |
| 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 | Late Adverse Event Incidence | Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100] | Posted | Number | event/100-patient years | 5 years |
|
|
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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 | Trifecta Valve Group | Subjects implanted with a Trifecta valve. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolism | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Johnson | St Jude Medical | 6517566803 | jjohnson101@sjm.com |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 5 years |
| Report 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. Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size. | 5 years |
| Mayo Clinic |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Mission Hospital | Asheville | North Carolina | 28801 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt Heart Institute | Nashville | Tennessee | 37232 | United States |
| Intermountain Heart & Lung Surgical Associates | Murray | Utah | 84157 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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 analyzed is those subjects with a visit and completed assessment | Posted | Number | participants | 5 years |
|
|
|
| Secondary | Report 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. Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size. | Aortic valve mean gradient at 5 years for participants analyzed with a visit and completed assessment | Posted | Mean | Standard Deviation | mmHg | 5 years |
|
|
|
| 39 |
| 245 |
| 0 |
| 245 |
| Valve thrombosis | Cardiac disorders | Systematic Assessment |
|
| Major bleed | Vascular disorders | Systematic Assessment |
|
| Nonstructural dysfunction | Cardiac disorders | Systematic Assessment |
|
| Endocarditis | Cardiac disorders | Systematic Assessment |
|
| Clinically significant hemolysis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Structural deterioration | Cardiac disorders | Systematic Assessment |
|
| Reoperation | Surgical and medical procedures | Systematic Assessment |
|
| Valve related mortality | Cardiac disorders | Systematic Assessment |
|
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| Title | Measurements |
|---|
|
| NYHA IV |
|
| Title | Measurements |
|---|---|
|
| 25mm |
|
| 27mm |
|
| 29mm |
|