Heart Valve Diseases
Conditions
Keywords
Trifecta Valve
Brief summary
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
Detailed description
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.
Interventions
DEVICETrifecta valve
surgical replacement of aortic valve
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects implanted with a Trifecta valve at one of the US sites of the IDE study. * Subject met eligibility criteria of IDE study * Subject agrees to complete study follow-up visits * Subject provides written informed consent
Exclusion criteria
* Subject currently participating in another device or drug study * Subject unable or unwilling to return for study follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Adverse Event Incidence | 5 years | 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:\[(Number of late adverse events/sum of late patient years) x 100\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterize Patient NYHA Functional Classification Status | 5 years | 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. |
| Report the Hemodynamic Performance of the Valve | 5 years | 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 Valve Group Subjects implanted with a Trifecta valve. | 245 |
| Total | 245 |
Baseline characteristics
| Characteristic | Trifecta Valve Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 200 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 72 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment United States | 245 participants |
| Sex: Female, Male Female | 73 Participants |
| Sex: Female, Male Male | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 245 |
| serious Total, serious adverse events | 39 / 245 |
Outcome results
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:\[(Number of late adverse events/sum of late patient years) x 100\]
Time frame: 5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trifecta Valve Group | Late Adverse Event Incidence | Thromboembolism | 7 event/100-patient years |
| Trifecta Valve Group | Late Adverse Event Incidence | Valve thrombosis | 0 event/100-patient years |
| Trifecta Valve Group | Late Adverse Event Incidence | Nonstructural Dysfunction | 0 event/100-patient years |
| Trifecta Valve Group | Late Adverse Event Incidence | Structural Deterioration | 4 event/100-patient years |
| Trifecta Valve Group | Late Adverse Event Incidence | Mortality | 9 event/100-patient years |
| Trifecta Valve Group | Late Adverse Event Incidence | Endocarditis | 0 event/100-patient years |
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.
Time frame: 5 years
Population: Number of participants analyzed is those subjects with a visit and completed assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trifecta Valve Group | Characterize Patient NYHA Functional Classification Status | NYHA I | 171 participants |
| Trifecta Valve Group | Characterize Patient NYHA Functional Classification Status | NYHA II | 16 participants |
| Trifecta Valve Group | Characterize Patient NYHA Functional Classification Status | NYHA III | 2 participants |
| Trifecta Valve Group | Characterize Patient NYHA Functional Classification Status | NYHA IV | 0 participants |
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.
Time frame: 5 years
Population: Aortic valve mean gradient at 5 years for participants analyzed with a visit and completed assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trifecta Valve Group | Report the Hemodynamic Performance of the Valve | 19mm | 15.4 mmHg | Standard Deviation 5.9 |
| Trifecta Valve Group | Report the Hemodynamic Performance of the Valve | 21mm | 10.4 mmHg | Standard Deviation 5.6 |
| Trifecta Valve Group | Report the Hemodynamic Performance of the Valve | 23mm | 9.2 mmHg | Standard Deviation 4.9 |
| Trifecta Valve Group | Report the Hemodynamic Performance of the Valve | 25mm | 7.9 mmHg | Standard Deviation 3.7 |
| Trifecta Valve Group | Report the Hemodynamic Performance of the Valve | 27mm | 8.4 mmHg | Standard Deviation 8.8 |
| Trifecta Valve Group | Report the Hemodynamic Performance of the Valve | 29mm | 6.1 mmHg | Standard Deviation 2.3 |