Aortic Valve Incompetence, Aortic Valve Insufficiency, Aortic Valve Stenosis, Regurgitation, Aortic Valve
Conditions
Keywords
aortic valve, heart valve, tissue valve, bioprosthesis, valve disorder, valve disease, cardiac surgery, aortic valve stenosis, aortic valve regurgitation
Brief summary
To confirm the clinical safety and effectiveness of the Trifecta valve.
Detailed description
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.
Interventions
Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time). * Legal age. * Signed informed consent prior to surgery. * Willing to complete all follow-up requirements.
Exclusion criteria
* Pregnant or nursing women. * Have already had a valve replaced other than the aortic valve. * Needs another valve replaced. * Cannot return for required follow-up visits. * Have active endocarditis. * Acute preoperative neurological event (such as a stroke). * Renal dialysis. * History of substance abuse within one year, or a prison inmate. * Participating in another study. * Life expectancy less than two years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Adverse Event Rates | Events occurring greater than or equal to 31 days post-implant. | 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:\[(Number of late adverse events/sum of late patient years) x 100\] |
| Characterize Patient NYHA Functional Classification Status. | 1 year | 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. |
| Characterize the Hemodynamic Performance of the Valve. | 1 year | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trifecta Aortic Heart Valve All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve. | 1,014 |
| Total | 1,014 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 41 |
| Overall Study | Device Explant | 6 |
| Overall Study | Did not meet eligibility criteria | 8 |
| Overall Study | Lost to Follow-up | 21 |
Baseline characteristics
| Characteristic | Trifecta Aortic Heart Valve |
|---|---|
| Age, Continuous | 72.5 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 364 Participants |
| Sex: Female, Male Male | 650 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,014 |
| serious Total, serious adverse events | 147 / 1,014 |
Outcome results
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.
Time frame: 1 year
Population: Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trifecta Aortic Heart Valve | Characterize Patient NYHA Functional Classification Status. | NYHA I at 1 year | 85.3 percentage of participants |
| Trifecta Aortic Heart Valve | Characterize Patient NYHA Functional Classification Status. | NYHA II at 1 year | 13.5 percentage of participants |
| Trifecta Aortic Heart Valve | Characterize Patient NYHA Functional Classification Status. | NYHA III at 1 year | 1.2 percentage of participants |
| Trifecta Aortic Heart Valve | Characterize Patient NYHA Functional Classification Status. | NYHA IV at 1 year | 0 percentage of participants |
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.
Time frame: 1 year
Population: Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trifecta Aortic Heart Valve | Characterize the Hemodynamic Performance of the Valve. | 19 mm Mean Gradient (1 year) | 10.7 mm Hg | Standard Deviation 4.6 |
| Trifecta Aortic Heart Valve | Characterize the Hemodynamic Performance of the Valve. | 21 mm Mean Gradient (1 year) | 8.1 mm Hg | Standard Deviation 3.5 |
| Trifecta Aortic Heart Valve | Characterize the Hemodynamic Performance of the Valve. | 23 mm Mean Gradient (1 year) | 7.2 mm Hg | Standard Deviation 2.8 |
| Trifecta Aortic Heart Valve | Characterize the Hemodynamic Performance of the Valve. | 25 mm Mean Gradient (1 year) | 6.2 mm Hg | Standard Deviation 2.7 |
| Trifecta Aortic Heart Valve | Characterize the Hemodynamic Performance of the Valve. | 27 mm Mean Gradient (1 year) | 4.8 mm Hg | Standard Deviation 2 |
| Trifecta Aortic Heart Valve | Characterize the Hemodynamic Performance of the Valve. | 29 mm Mean Gradient (1 year) | 4.7 mm Hg | Standard Deviation 1.6 |
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:\[(Number of late adverse events/sum of late patient years) x 100\]
Time frame: Events occurring greater than or equal to 31 days post-implant.
Population: Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trifecta Aortic Heart Valve | Late Adverse Event Rates | Major Bleed | 2.61 percentage of events/late patient years |
| Trifecta Aortic Heart Valve | Late Adverse Event Rates | Thromboembolism | 1.90 percentage of events/late patient years |
| Trifecta Aortic Heart Valve | Late Adverse Event Rates | Valve Thrombosis | 0 percentage of events/late patient years |
| Trifecta Aortic Heart Valve | Late Adverse Event Rates | Nonstructural Dysfunction | 0.12 percentage of events/late patient years |
| Trifecta Aortic Heart Valve | Late Adverse Event Rates | Endocarditis | 1.07 percentage of events/late patient years |
| Trifecta Aortic Heart Valve | Late Adverse Event Rates | Clinically Significant Hemolysis | 0.0 percentage of events/late patient years |
| Trifecta Aortic Heart Valve | Late Adverse Event Rates | Structural Deterioration | 0.12 percentage of events/late patient years |
| Trifecta Aortic Heart Valve | Late Adverse Event Rates | Valve Reoperation | 0.59 percentage of events/late patient years |
| Trifecta Aortic Heart Valve | Late Adverse Event Rates | Mortality (All Cause) | 2.72 percentage of events/late patient years |