Aortic Valve Incompetence, Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis
Conditions
Keywords
Aortic valve, Heart valve, Tissue valve, Bioprosthesis
Brief summary
The Trifecta™ LTFU Study is a single-arm, multi-center, prospective, non-randomized, post-market study conducted in the United States and Canada to collect long-term safety and effectiveness data through 10 years after implant of the Trifecta™ aortic bioprosthetic valve. The Trifecta™ is a tri-leaflet stented pericardial valve designed for supraannular placement in the aortic position. The Trifecta™ LTFU Study is an extension of the Trifecta™ Investigational Device Exemption (IDE) Study (NCT00475709) conducted to support United States Food and Drug Administration (FDA) approval of the Trifecta™ valve. All Trifecta™ LTFU Study subjects received Trifecta™ valve implants during participation in the Trifecta™ IDE study and subsequently consented to extended annual follow-up through 10 years under the Trifecta™ LTFU protocol.
Detailed description
This clinical study was designed as an extension of the Trifecta™ IDE Study supporting FDA approval of the Trifecta™ valve. A total of 11 Trifecta™ IDE Study investigational sites in the United States (n=9) and Canada (n=2) participated in the Trifecta™ LTFU Study. Study enrollment included 329 subjects implanted from 2007 through 2009 at these 11 sites during the IDE Study who consented to participate in continued annual follow-up through 10 years post-implant. Of these 329 subjects, 140 also participated in the FDA-mandated Trifecta™ Post-Approval Study (PAS, NCT01514162) prior to consenting to additional annual follow-up under the Trifecta™ LTFU protocol. The remaining 189 subjects entered the Trifecta™ LTFU Study directly from the Trifecta™ IDE Study. The Trifecta™ LTFU Study database subsumes all data collected in the 329 participants under the Trifecta™ IDE and Trifecta™ PAS protocols and extends these data through 10 years from each subject's original date of implant in the Trifecta™ IDE Study. The Trifecta™ LTFU Study data thus encompass 10 years of continuous annual post-implant follow-up in the 329 participants as well as their pre-implant Baseline Visit data. Data collected includes adverse events, assessments of heart failure symptoms by New York Heart Association (NYHA) functional classification, and echocardiographic assessments of Trifecta™ valve function.
Interventions
DEVICETrifecta™ Valve
Aortic valve replacement with the Trifecta™ aortic bioprosthesis.
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
1. Patient currently has a Trifecta™ aortic valve that was implanted at one of the U.S. or Canadian investigational sites during the Trifecta™ IDE study. 2. Patient met eligibility criteria prior to enrollment in the Trifecta™ IDE study. 3. Patient agrees to complete all required follow-up visits. 4. Patient provided written informed consent prior to any study related procedure, as approved by the governing Institutional Review Board (IRB) or the Ethics Committee (EC) of the investigational site.
Exclusion criteria
1\. Patient is currently participating or planning to participate in any other study unless approved by the Sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant | 10 years post-implant | Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve implantation 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 |
|---|---|---|
| Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant | 10 years post-implant | 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. |
| Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant | 10 years post-implant | 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. |
| Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant | 10 years post-implant | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Late Adverse Events Per 100 Patient-Years of Follow-up | 31 days through 10 years post-implant | Late adverse events are defined those occurring from 31 days through 10 years post-implant. This outcome measure is calculated by dividing the number of late adverse events of each type by the total number of patient-years of follow-up accumulated from 31 days through 10 years post-implant, expressed in hundreds of years. |
| Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant | Preoperative through 10 years | The New York Heart Association (NYHA) functional classification system relates heart failure symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. |
| Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size | 10 years post-implant | Average of participants' mean aortic transvalvular pressure gradient measured by echocardiography at 10 years post-implant. Averages are reported for each valve size separately. The mean transvalvular pressure gradient is the mean difference in pressure between the inlet side and outlet side of the aortic valve during systole, measured in millimeters of mercury (mmHg). |
| Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size | 10 years post-implant | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve estimated by echocardiography. Mean EOA in square centimeters is reported separately for each valve size. |
| Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant | 10 years post-implant | Regurgitation occurs when the aortic valve does not fully seal, allowing backflow of blood through the closed valve. The amount of aortic regurgitation in this study was graded as none, trivial, mild, moderate or severe by echocardiographic assessment. Moderate or severe aortic regurgitation can cause symptoms of heart failure, such as fatigue, shortness of breath and exercise intolerance. |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 329 subjects were enrolled into the Trifecta™ Long Term Follow-Up (LTFU) Study at 11 sites in the United States and Canada. All 329 subjects had received Trifecta™ implants in 2007, 2008 and 2009 during their participation in the Trifecta™ Investigational Device Exemption Study (IDE) Study (NCT00475709). Trifecta™ LTFU study enrollments occurred between 02 July, 2012 and 27 March, 2017. The final 10-years post-Trifecta™-implant follow-up visit was completed on 26 September, 2019.
Pre-assignment details
The 329 subjects participated in the pre-market Trifecta™ IDE Study used to obtain Food and Drug Administration (FDA) approval. Thereafter, they consented to extended follow-up in the Trifecta™ LTFU Study. Additionally, 140 of the 329 participated in the FDA-required Trifecta™ Post-Approval Study (PAS, NCT01514162) before entering the LTFU Study. Trifecta™ LTFU data subsume the 329 subjects' data from the IDE and PAS protocols and extend these data through 10-years from Trifecta™ implant.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Previously Implanted With a Trifecta™ Valve Subjects enrolled in this clinical study were implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study conducted to obtain FDA approval. Baseline data are from the pre-implant Baseline and Implant Visits in the Trifecta™ IDE Study. | 329 |
| Total | 329 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 67 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) or Surgical Explant | 60 |
| Overall Study | Withdrawal by Subject | 23 |
Baseline characteristics
| Characteristic | Subjects Previously Implanted With a Trifecta™ Valve | — |
|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 8.9 | — |
| Aortic Cross Clamp Time (minutes) | 78.7 minutes STANDARD_DEVIATION 34 | — |
| Cardiopulmonary Bypass Time (minutes) | 103.8 minutes STANDARD_DEVIATION 44.8 | — |
| Concomitant Coronary Artery Bypass Grafting (CABG) | 104 Participants | — |
| History of Coronary Artery Disease | 180 Participants | — |
| History of Diabetes | 80 Participants | — |
| History of Hypertension | 260 Participants | — |
| History of Smoking | 188 Participants | — |
| Implanted Valve Size 19 mm | 22 Participants | — |
| Implanted Valve Size 21 mm | 78 Participants | — |
| Implanted Valve Size 23 mm | 113 Participants | — |
| Implanted Valve Size 25 mm | 86 Participants | — |
| Implanted Valve Size 27 mm | 24 Participants | — |
| Implanted Valve Size 29 mm | 6 Participants | — |
| No Concomitant Procedure | 160 Participants | — |
| Preoperative Antiplatelet Medication | 24 Participants | — |
| Preoperative Aspirin | 228 Participants | — |
| Preoperative Coumarin Derivatives | 33 Participants | — |
| Preoperative New York Heart Association (NYHA) functional classification III or IV | 140 Participants | — |
| Previous Cardiovascular Surgery/Procedure | 85 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 102 participants | — |
| Region of Enrollment United States | 227 participants | — |
| Sex: Female, Male Female | 105 Participants | — |
| Sex: Female, Male Male | 224 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 67 / 329 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 272 / 329 |
Outcome results
Primary
Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant
Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve implantation 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 post-implant
Population: Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Previously Implanted With a Trifecta™ Valve | Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant | 75.7 Percentage of Participants |
Secondary
Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant
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 post-implant
Population: Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Previously Implanted With a Trifecta™ Valve | Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant | 77.1 Percentage of Participants |
Secondary
Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant
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 post-implant
Population: Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Previously Implanted With a Trifecta™ Valve | Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant | 68.4 Percentage of Participants |
Secondary
Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant
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 post-implant
Population: Analysis population includes participants implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study who consented to be enrolled in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Previously Implanted With a Trifecta™ Valve | Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant | 98.4 Percentage of Participants |
Other Pre-specified
Number of Late Adverse Events Per 100 Patient-Years of Follow-up
Late adverse events are defined those occurring from 31 days through 10 years post-implant. This outcome measure is calculated by dividing the number of late adverse events of each type by the total number of patient-years of follow-up accumulated from 31 days through 10 years post-implant, expressed in hundreds of years.
Time frame: 31 days through 10 years post-implant
Population: Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Late Adverse Events Per 100 Patient-Years of Follow-up | All-Cause Mortality | 2.34 Number of events per 100 patient-years |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Late Adverse Events Per 100 Patient-Years of Follow-up | Valve-Related Mortality | 0.17 Number of events per 100 patient-years |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Late Adverse Events Per 100 Patient-Years of Follow-up | Structural Valve Deterioration (SVD) | 2.93 Number of events per 100 patient-years |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Late Adverse Events Per 100 Patient-Years of Follow-up | Reoperation for SVD (surgical explant or transcatheter valve-in-valve implant) | 2.27 Number of events per 100 patient-years |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Late Adverse Events Per 100 Patient-Years of Follow-up | Thromboembolism | 0.52 Number of events per 100 patient-years |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Late Adverse Events Per 100 Patient-Years of Follow-up | Valve Thrombosis | 0.03 Number of events per 100 patient-years |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Late Adverse Events Per 100 Patient-Years of Follow-up | Major Bleeding | 1.05 Number of events per 100 patient-years |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Late Adverse Events Per 100 Patient-Years of Follow-up | Major Paravalvular Leak | 0.00 Number of events per 100 patient-years |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Late Adverse Events Per 100 Patient-Years of Follow-up | Endocarditis | 0.17 Number of events per 100 patient-years |
Other Pre-specified
Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant
Regurgitation occurs when the aortic valve does not fully seal, allowing backflow of blood through the closed valve. The amount of aortic regurgitation in this study was graded as none, trivial, mild, moderate or severe by echocardiographic assessment. Moderate or severe aortic regurgitation can cause symptoms of heart failure, such as fatigue, shortness of breath and exercise intolerance.
Time frame: 10 years post-implant
Population: Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study and who have aortic regurgitation assessment data available at 10 years post-implant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant | Mild | 30 Participants |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant | None | 60 Participants |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant | Trivial | 53 Participants |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant | Moderate | 12 Participants |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant | Severe | 0 Participants |
Other Pre-specified
Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant
The New York Heart Association (NYHA) functional classification system relates heart failure symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time frame: Preoperative through 10 years
Population: Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study and have available Preoperative and/or 10-year NYHA classification data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant | 10 Years | NYHA Class I | 111 Participants |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant | Preoperative | NYHA Class I | 23 Participants |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant | Preoperative | NYHA Class II | 166 Participants |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant | Preoperative | NYHA Class III | 133 Participants |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant | Preoperative | NYHA Class IV | 7 Participants |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant | 10 Years | NYHA Class II | 26 Participants |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant | 10 Years | NYHA Class III | 14 Participants |
| Subjects Previously Implanted With a Trifecta™ Valve | Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant | 10 Years | NYHA Class IV | 1 Participants |
Other Pre-specified
Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size
Average of participants' mean aortic transvalvular pressure gradient measured by echocardiography at 10 years post-implant. Averages are reported for each valve size separately. The mean transvalvular pressure gradient is the mean difference in pressure between the inlet side and outlet side of the aortic valve during systole, measured in millimeters of mercury (mmHg).
Time frame: 10 years post-implant
Population: Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study and who have 10-year mean gradient data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size | 19 mm | 24.9 mmHg | Standard Deviation 12.4 |
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size | 21 mm | 17.7 mmHg | Standard Deviation 8.3 |
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size | 23 mm | 16.0 mmHg | Standard Deviation 9.1 |
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size | 25 mm | 13.2 mmHg | Standard Deviation 12.4 |
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size | 27 mm | 8.7 mmHg | Standard Deviation 5.7 |
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size | 29 mm | 11.0 mmHg | Standard Deviation 3 |
Other Pre-specified
Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve estimated by echocardiography. Mean EOA in square centimeters is reported separately for each valve size.
Time frame: 10 years post-implant
Population: Analysis population includes participants implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study who consented to be enrolled in this study and who have EOA data available at 10 years post-implant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size | 19 mm | 1.0 square centimeters | Standard Deviation 0.3 |
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size | 21 mm | 1.2 square centimeters | Standard Deviation 0.3 |
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size | 23 mm | 1.4 square centimeters | Standard Deviation 0.3 |
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size | 25 mm | 1.7 square centimeters | Standard Deviation 0.5 |
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size | 27 mm | 1.7 square centimeters | Standard Deviation 0.4 |
| Subjects Previously Implanted With a Trifecta™ Valve | Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size | 29 mm | 1.7 square centimeters | Standard Deviation 0.1 |