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The study was terminated approximately 6 months earlier than planned because 227 subjects (59% more than anticipated) had already completed 10-Year Visits due to lower than expected subject attrition.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifecta™ Valve Group | Subjects implanted with the Trifecta™ aortic bioprosthesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifecta™ aortic bioprosthesis | Device | Surgical aortic valve replacement with the Trifecta™ valve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| Freedom From Valve Related Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that are candidates for implantation or have been implanted over the past 9 months with a Trifecta™ aortic valve.
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| Name | Affiliation | Role |
|---|---|---|
| Sven Lehmann | Universitat Herzzentrum Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Herzzentrum Leipzig | Leipzig | 04289 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trifecta™ Valve Group | Subjects implanted with the Trifecta™ aortic bioprosthesis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trifecta™ Valve Group | Subjects implanted with the Trifecta™ aortic bioprosthesis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | 10 years |
|
10 years
Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
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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 | Implantation of the Trifecta Valve: Implantation of the bioprothesis valve, Trifecta Valve |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and Lymphatic System Disorder | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Disorder | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yunlong (Phil) Zhang, MD, MS, Clinical Consultant | Abbott Medical Devices, Structure Heart Valves | 669-203-9308 | phil.yl.zhang@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2010 | Nov 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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. |
| 10 years |
| 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. | 10 years |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Subject Noncompliance |
|
| Study Terminated by Sponsor |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Characteristics | NYHA functional classification is a widely used four class ( I, II, III, and IV) measure of the severity of heart failure symptoms. Class I and II patients experience no or slight limitations on their physical activity. Class III and IV patients experience marked limitations on their physical activity or are unable to perform any physical activity without discomfort. | Count of Participants | Participants |
|
| Implanted Device Size | Count of Participants | 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. | The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | 10 years |
|
|
|
| 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. | The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | 10 years |
|
|
|
| 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. | The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | 10 years |
|
|
|
| 449 |
| 1,151 |
| 952 |
| 1,151 |
| 562 |
| 1,151 |
| Cardiac disorders | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Congenital, Familial and Genetic Disorders | Congenital, familial and genetic disorders | MedDRA 11.0 | Systematic Assessment |
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| Ear and Labyrinth Disorders | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
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| Endocrine Disorder | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
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| Eye Disorders | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| General Disorders | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Hepatobiliary Disorders | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
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| Immune System Disorders | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
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| Infections and Infestations | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Investigations | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Metabolism and Nutrition Disorder | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Neoplasms, Benign, Malignant and Unspecified Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
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| Nervous System Disorder | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Product Issues | Product Issues | MedDRA 11.0 | Systematic Assessment |
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| Psychiatric Disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Renal and Urinary Disorder | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Reproductive System and Breast Disorder | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
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| Respiratory, Thoracic and Mediastinal Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Skin and Subcutaneous Tissue Disorder | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Social Circumstances | Social circumstances | MedDRA 11.0 | Systematic Assessment |
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| Surgical and Medical Procedures | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
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| Vascular Disorder | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
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