An observational study in Aortic Valve Insufficiency, Aortic Valve Regurgitation and Aortic Valve Stenosis, sponsored by Abbott Medical Devices. Completed at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Abbott Medical Devices · Observational
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.
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 282 are open to participants now.
This study's enrollment of 329 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects previously implanted with a Trifecta prosthetic valve
Exclusion Criteria:
Subjects enrolled in this clinical study were implanted with the Trifecta™ aortic bioprosthetic valve during 2007, 2008 and 2009 as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
Device: Trifecta™ Valve
Aortic valve replacement with the Trifecta™ aortic bioprosthesis.
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
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
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
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
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
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
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
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
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
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.
| Milestone | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Started | 329 |
| Completed | 159 |
| Not completed | 170 |
| Withdrew: Death | 67 |
| Withdrew: Valve-in-valve transcatheter aortic valve implantation (tavi) or surgical explant | 60 |
| Withdrew: Withdrawal by subject | 23 |
| Withdrew: Lost to follow-up | 12 |
| Withdrew: Protocol violation | 5 |
| Withdrew: Physician decision | 3 |
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.
| Percentage of Participants | 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 (70.0 to 80.5) |
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 | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant | 77.1 (71.6 to 81.6) |
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 | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant | 98.4 (95.7 to 99.4) |
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.
| Percentage of Participants | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant | 68.4 (62.1 to 73.8) |
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 events per 100 patient-years | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| All-Cause Mortality | 2.34 |
| Valve-Related Mortality | 0.17 |
| Structural Valve Deterioration (SVD) | 2.93 |
| Reoperation for SVD (surgical explant or transcatheter valve-in-valve implant) | 2.27 |
| Thromboembolism | 0.52 |
| Valve Thrombosis | 0.03 |
| Major Bleeding | 1.05 |
| Major Paravalvular Leak | 0.00 |
| Endocarditis | 0.17 |
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).
| mmHg | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| 19 mm | 24.9 ± 12.4 |
| 21 mm | 17.7 ± 8.3 |
| 23 mm | 16.0 ± 9.1 |
| 25 mm | 13.2 ± 12.4 |
| 27 mm | 8.7 ± 5.7 |
| 29 mm | 11.0 ± 3.0 |
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.
| square centimeters | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| 19 mm | 1.0 ± 0.3 |
| 21 mm | 1.2 ± 0.3 |
| 23 mm | 1.4 ± 0.3 |
| 25 mm | 1.7 ± 0.5 |
| 27 mm | 1.7 ± 0.4 |
| 29 mm | 1.7 ± 0.1 |
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.
| Participants | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| None | 60 |
| Trivial | 53 |
| Mild | 30 |
| Moderate | 12 |
| Severe | 0 |
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 | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Preoperative — NYHA Class I | 23 |
| Preoperative — NYHA Class II | 166 |
| Preoperative — NYHA Class III | 133 |
| Preoperative — NYHA Class IV | 7 |
| 10 Years — NYHA Class I | 111 |
| 10 Years — NYHA Class II | 26 |
| 10 Years — NYHA Class III | 14 |
| 10 Years — NYHA Class IV | 1 |
Collected over 10 Years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects Previously Implanted With a Trifecta Valve | 67/329 (20.4%) | 272/329 (82.7%) | — |
| Event | Subjects Previously Implanted With a Trifecta Valve |
|---|---|
| Cardiac ArrhythmiasCardiac disorders | 93/329 |
| Joint DisordersMusculoskeletal and connective tissue disorders | 55/329 |
| Major BleedingBlood and lymphatic system disorders | 42/329 |
| Heart Failure Signs and SymptomsCardiac disorders | 34/329 |
| Structural Valve Deterioration, Transcatheter Valve-in-Valve ImplantCardiac disorders | 34/329 |
| Structural Valve Deterioration, ExplantedCardiac disorders | 31/329 |
| MalignanciesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 28/329 |
| Myocardial IschemiaCardiac disorders | 26/329 |
| Lower Respiratory Tract And Lung InfectionsInfections and infestations | 24/329 |
| Urinary Tract DisordersRenal and urinary disorders | 24/329 |
| Age, Continuous(years) | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Mean | 69.7 ± 8.9 |
| Sex: Female, Male(Participants) | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Female | 105 |
| Male | 224 |
| Race and Ethnicity Not Collected(Participants) | Subjects Previously Implanted With a Trifecta™ Valve |
|---|
| Region of Enrollment(participants) | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Canada | 102 |
| United States | 227 |
| Preoperative New York Heart Association (NYHA) functional classification III or IV(Participants) | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Count of participants | 140 |
| History of Coronary Artery Disease(Participants) | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Count of participants | 180 |
| History of Hypertension(Participants) | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Count of participants | 260 |
| History of Diabetes(Participants) | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Count of participants | 80 |
10 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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