Aortic Valve Disease
Conditions
Brief summary
The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve. The Trifecta™ valve is a stented surgical aortic bioprosthesis with bovine pericardial leaflets designed for supra annular placement.
Interventions
DEVICETrifecta™ aortic bioprosthesis
Surgical aortic valve replacement with the Trifecta™ valve.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients implanted for less than 9 months with a Trifecta™ valve, or patients who are candidates for implant with a Trifecta™ valve, as per current guidelines * Patient requires aortic valve replacement. * Patient is legal age in host country. * Patients must be able and willing to provide written informed consent to participate in this investigation * Patients must be willing and able to comply with all follow-up requirements
Exclusion criteria
* Patients with contraindication for cardiac surgery * Patients who are pregnant. * Patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits. * Patient has active endocarditis * Patient has had an acute preoperative neurological event defined as patient has not returned to baseline 30 days prior to the planned valve implantation surgery. * Patient is undergoing renal dialysis. * Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate. * Patient has a documented thrombus in left atrium or left ventricle. * Patient had in the past mitral or tricuspid valve replacement. * Patient needs mitral and/or tricuspid valve replacement. * Patient has an Ejection Fraction \< 25% * Patient had the Trifecta™ valve implanted as part of this study, but then had the device explanted * Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm. * Patient has a life expectancy less than two years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Actuarial Freedom From Reintervention Due to Structural Valve Deterioration | 10 years | Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve intervention for treatment of structural deterioration of the Trifecta™ valve through 10 years post-implant. This percentage is estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Actuarial Freedom From All-cause Mortality | 10 years | Percentage of participants free of death from any cause through 10 years after implant with the Trifecta™ valve, estimated from time-to-event data using the Kaplan-Meier estimator. |
| Freedom From Valve Related Mortality | 10 years | Percentage of participants free from death related to the Trifecta™ valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Valve-related mortality includes deaths due to any of the following events involving the study valve: structural valvular deterioration, nonstructural valve dysfunction, valve thrombosis, embolism, bleeding events, endocarditis, or reoperation. Sudden, unexplained deaths of participants implanted with the Trifecta™ valve are also counted as valve-related mortality. |
| Freedom From Structural Valve Deterioration | 10 years | Percentage of participants free of structural deterioration of the Trifecta valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. The presence of structural valve deterioration is determined by direct visualization of the valve at explant or autopsy or by echocardiographic or other cardiac imaging criteria for assessment of valvular stenosis and regurgitation. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trifecta™ Valve Group Subjects implanted with the Trifecta™ aortic bioprosthesis | 1,151 |
| Total | 1,151 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 449 |
| Overall Study | Lost to Follow-up | 67 |
| Overall Study | Physician Decision | 9 |
| Overall Study | Study Terminated by Sponsor | 273 |
| Overall Study | Subject Noncompliance | 2 |
| Overall Study | System Explant | 67 |
| Overall Study | Transcatheter Aortic Valve-in-Valve Intervention | 28 |
| Overall Study | Withdrawal by Subject | 29 |
Baseline characteristics
| Characteristic | Trifecta™ Valve Group | — |
|---|---|---|
| Age, Continuous | 73.7 years STANDARD_DEVIATION 7.8 | — |
| Baseline Characteristics Baseline NYHA III/IV | 566 Participants | — |
| Baseline Characteristics Concomitant Coronary Artery Bypass Grafting | 360 Participants | — |
| Baseline Characteristics Concomitant Procedure (e.g., mitral or tricuspid valve repair, CABG, operator reported) | 627 Participants | — |
| Baseline Characteristics History of Coronary Artery Disease | 395 Participants | — |
| Baseline Characteristics History of Diabetes | 316 Participants | — |
| Baseline Characteristics History of Hypertension | 912 Participants | — |
| Baseline Characteristics Previous Cardiovascular Surgery or Procedure | 222 Participants | — |
| Implanted Device Size 19 mm | 115 Participants | — |
| Implanted Device Size 21 mm | 335 Participants | — |
| Implanted Device Size 23 mm | 411 Participants | — |
| Implanted Device Size 25 mm | 222 Participants | — |
| Implanted Device Size 27 mm | 57 Participants | — |
| Implanted Device Size 29 mm | 11 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 14 participants | — |
| Region of Enrollment Belgium | 7 participants | — |
| Region of Enrollment Canada | 54 participants | — |
| Region of Enrollment Denmark | 17 participants | — |
| Region of Enrollment France | 386 participants | — |
| Region of Enrollment Germany | 404 participants | — |
| Region of Enrollment Greece | 12 participants | — |
| Region of Enrollment Italy | 12 participants | — |
| Region of Enrollment Netherlands | 53 participants | — |
| Region of Enrollment Norway | 4 participants | — |
| Region of Enrollment Portugal | 4 participants | — |
| Region of Enrollment Spain | 153 participants | — |
| Region of Enrollment Switzerland | 20 participants | — |
| Region of Enrollment United Kingdom | 11 participants | — |
| Sex: Female, Male Female | 487 Participants | — |
| Sex: Female, Male Male | 664 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 449 / 1,151 |
| other Total, other adverse events | 562 / 1,151 |
| serious Total, serious adverse events | 952 / 1,151 |
Outcome results
Primary
Actuarial Freedom From Reintervention Due to Structural Valve Deterioration
Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve intervention for treatment of structural deterioration of the Trifecta™ valve through 10 years post-implant. This percentage is estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation.
Time frame: 10 years
Population: The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trifecta Valve™ Group | Actuarial Freedom From Reintervention Due to Structural Valve Deterioration | 85.0 percentage of participants |
Secondary
Actuarial Freedom From All-cause Mortality
Percentage of participants free of death from any cause through 10 years after implant with the Trifecta™ valve, estimated from time-to-event data using the Kaplan-Meier estimator.
Time frame: 10 years
Population: The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trifecta Valve™ Group | Actuarial Freedom From All-cause Mortality | 52.2 percentage of participants |
Secondary
Freedom From Structural Valve Deterioration
Percentage of participants free of structural deterioration of the Trifecta valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. The presence of structural valve deterioration is determined by direct visualization of the valve at explant or autopsy or by echocardiographic or other cardiac imaging criteria for assessment of valvular stenosis and regurgitation.
Time frame: 10 years
Population: The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trifecta Valve™ Group | Freedom From Structural Valve Deterioration | 76.0 percentage of participants |
Secondary
Freedom From Valve Related Mortality
Percentage of participants free from death related to the Trifecta™ valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Valve-related mortality includes deaths due to any of the following events involving the study valve: structural valvular deterioration, nonstructural valve dysfunction, valve thrombosis, embolism, bleeding events, endocarditis, or reoperation. Sudden, unexplained deaths of participants implanted with the Trifecta™ valve are also counted as valve-related mortality.
Time frame: 10 years
Population: The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trifecta Valve™ Group | Freedom From Valve Related Mortality | 81.6 percentage of participants |