Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To confirm the clinical safety and effectiveness of the Trifecta valve.
The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifecta Aortic Heart Valve | Experimental | All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifecta Aortic Heart Valve | Device | Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late Adverse Event Rates | 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] | Events occurring greater than or equal to 31 days post-implant. |
| 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. | 1 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. 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. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hartzell Schaff, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital | Los Angeles | California | 90033 | United States | ||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Implanted With Trifecta Valve | All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sarasota Memorial Hospital/Clinical Research Center |
| Sarasota |
| Florida |
| 34239 |
| United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| NYU Medical Center | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Mission Hospitals | Asheville | North Carolina | 28801 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Main Line Health Heart Center | Wynnewood | Pennsylvania | 19096 | United States |
| Vanderbilt Medical Center | Nashville | Tennessee | 37212 | United States |
| Cardiothoracic and Vascular Surgeons | Austin | Texas | 78756 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53201 | United States |
| Eligible of Analysis |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trifecta Aortic Heart Valve | All subjects enrolled into the study are implanted with the Trifecta Aortic 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 |
|
| 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 Rates | 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] | Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis. | Posted | Number | percentage of events/late patient years | Events occurring greater than or equal to 31 days post-implant. |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis. | Posted | Number | percentage of participants | 1 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. 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. | Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis. | Posted | Mean | Standard Deviation | mm Hg | 1 year |
|
|
Not provided
Early (adverse events occuring on or before 30 days post procedure) and Late(adverse events occurring greater than or equal to 31 days post procedure) are combined for the Valve Related Serious Adverse Event data analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Implanted With Trifecta Valve | 147 | 1,014 | 0 | 1,014 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinically Significant Hemolysis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thromboembolism | Cardiac disorders | Systematic Assessment |
| ||
| Valve Thrombosis | Cardiac disorders | Systematic Assessment |
| ||
| Major Bleed | General disorders | Systematic Assessment |
| ||
| Non-structural dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| Structural deterioration | Cardiac disorders | Systematic Assessment |
| ||
| Reoperation | Surgical and medical procedures | Systematic Assessment |
| ||
| Valve related Mortality | Cardiac disorders | Systematic Assessment |
|
Not provided
The SAEs reported are based on the Edmunds criteria noted in Edmunds LH, Clark RE, Cohn LH, Grunkemeier GL, Miller CM, Weisel RD. Guidelines for reporting Morbidity and Mortality after Cardiac Valvular Operations. Ann Thorac Surg 1996;62:932-5.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Erickson | St Jude Medical | 16517566580 | kaerickson@sjm.com |
| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Nonstructural Dysfunction |
|
| Endocarditis |
|
| Clinically Significant Hemolysis |
|
| Structural Deterioration |
|
| Valve Reoperation |
|
| Mortality (All Cause) |
|
|
|