Trifecta™ Long Term Follow-Up (LTFU) Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subjects previously implanted with a Trifecta™ valve in the Trifecta™ IDE Study 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
-
Patient met eligibility criteria prior to enrollment in the Trifecta™ IDE study.
-
Patient agrees to complete all required follow-up visits.
-
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:
- Patient is currently participating or planning to participate in any other study unless approved by the Sponsor.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | USC University Hospital | Los Angeles | California | United States | 90033 |
| 2 | Abbott Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 3 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 4 | Mission Health & Hospitals | Asheville | North Carolina | United States | 28801 |
| 5 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 6 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 7 | Main Line Health Center/Lankenau Hospital | Wynnewood | Pennsylvania | United States | 19096 |
| 8 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 9 | Intermountain Salt Lake Cardiovascular and Thoracic Surgery | Salt Lake City | Utah | United States | 84103 |
| 10 | St. Paul's Hospital | Vancouver | British Columbia | Canada | V6Z 1Y6 |
| 11 | Institut de Cardiologie de Quebec (Hôpital Laval) | Quebec | Canada | G1V 4G5 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Director: Angelic Roach, Abbott Medical Devices
Study Documents (Full-Text)
More Information
Publications
- Bavaria JE, Desai ND, Cheung A, Petracek MR, Groh MA, Borger MA, Schaff HV. The St Jude Medical Trifecta aortic pericardial valve: results from a global, multicenter, prospective clinical study. J Thorac Cardiovasc Surg. 2014 Feb;147(2):590-7. doi: 10.1016/j.jtcvs.2012.12.087. Epub 2013 Mar 7.
- Goldman S, Cheung A, Bavaria JE, Petracek MR, Groh MA, Schaff HV. Midterm, multicenter clinical and hemodynamic results for the Trifecta aortic pericardial valve. J Thorac Cardiovasc Surg. 2017 Mar;153(3):561-569.e2. doi: 10.1016/j.jtcvs.2016.09.089. Epub 2016 Nov 18.
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Study Results
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 Detail | 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. |
| Arm/Group Title | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Arm/Group Description | Subjects enrolled in this clinical study received the Trifecta™ valve during the Trifecta™ IDE Study conducted to obtain FDA approval. |
| Period Title: Overall Study | |
| STARTED | 329 |
| COMPLETED | 159 |
| NOT COMPLETED | 170 |
Baseline Characteristics
| Arm/Group Title | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 329 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
69.7
(8.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
105
31.9%
|
| Male |
224
68.1%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| Canada |
102
31%
|
| United States |
227
69%
|
| Preoperative New York Heart Association (NYHA) functional classification III or IV (Count of Participants) | |
| Count of Participants [Participants] |
140
42.6%
|
| History of Coronary Artery Disease (Count of Participants) | |
| Count of Participants [Participants] |
180
54.7%
|
| History of Hypertension (Count of Participants) | |
| Count of Participants [Participants] |
260
79%
|
| History of Diabetes (Count of Participants) | |
| Count of Participants [Participants] |
80
24.3%
|
| History of Smoking (Count of Participants) | |
| Count of Participants [Participants] |
188
57.1%
|
| Preoperative Coumarin Derivatives (Count of Participants) | |
| Count of Participants [Participants] |
33
10%
|
| Preoperative Aspirin (Count of Participants) | |
| Count of Participants [Participants] |
228
69.3%
|
| Preoperative Antiplatelet Medication (Count of Participants) | |
| Count of Participants [Participants] |
24
7.3%
|
| Previous Cardiovascular Surgery/Procedure (Count of Participants) | |
| Count of Participants [Participants] |
85
25.8%
|
| No Concomitant Procedure (Count of Participants) | |
| Count of Participants [Participants] |
160
48.6%
|
| Concomitant Coronary Artery Bypass Grafting (CABG) (Count of Participants) | |
| Count of Participants [Participants] |
104
31.6%
|
| Cardiopulmonary Bypass Time (minutes) (minutes) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [minutes] |
103.8
(44.8)
|
| Aortic Cross Clamp Time (minutes) (minutes) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [minutes] |
78.7
(34)
|
| Implanted Valve Size (Count of Participants) | |
| 19 mm |
22
6.7%
|
| 21 mm |
78
23.7%
|
| 23 mm |
113
34.3%
|
| 25 mm |
86
26.1%
|
| 27 mm |
24
7.3%
|
| 29 mm |
6
1.8%
|
Outcome Measures
| Title | Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Arm/Group Description | Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval. |
| Measure Participants | 329 |
| Number (95% Confidence Interval) [Percentage of Participants] |
75.7
23%
|
| Title | Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Arm/Group Description | Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval. |
| Measure Participants | 329 |
| Number (95% Confidence Interval) [Percentage of Participants] |
77.1
23.4%
|
| Title | Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Arm/Group Description | Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval. |
| Measure Participants | 329 |
| Number (95% Confidence Interval) [Percentage of Participants] |
98.4
29.9%
|
| Title | Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Arm/Group Description | Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval. |
| Measure Participants | 329 |
| Number (95% Confidence Interval) [Percentage of Participants] |
68.4
20.8%
|
| Title | Number of Late Adverse Events Per 100 Patient-Years of Follow-up |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Arm/Group Description | Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval. |
| Measure Participants | 329 |
| 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
|
| Title | Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Arm/Group Description | Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval. |
| Measure Participants | 155 |
| 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)
|
| Title | Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Arm/Group Description | Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval. |
| Measure Participants | 151 |
| 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)
|
| Title | Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Arm/Group Description | Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval. |
| Measure Participants | 155 |
| None |
60
18.2%
|
| Trivial |
53
16.1%
|
| Mild |
30
9.1%
|
| Moderate |
12
3.6%
|
| Severe |
0
0%
|
| Title | Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Subjects Previously Implanted With a Trifecta™ Valve |
|---|---|
| Arm/Group Description | Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval. |
| Measure Participants | 329 |
| NYHA Class I |
23
7%
|
| NYHA Class II |
166
50.5%
|
| NYHA Class III |
133
40.4%
|
| NYHA Class IV |
7
2.1%
|
| NYHA Class I |
111
33.7%
|
| NYHA Class II |
26
7.9%
|
| NYHA Class III |
14
4.3%
|
| NYHA Class IV |
1
0.3%
|
Adverse Events
| Time Frame | 10 Years | |
|---|---|---|
| Adverse Event Reporting Description | Adverse event data collection includes all serious adverse events recorded in each participant from the time of their Trifecta™ implant under the Trifecta™ IDE study in 2007, 2008 and 2009 through the end of the Trifecta™ LTFU study in 2019. Non-serious adverse event data were not collected. | |
| Arm/Group Title | Subjects Previously Implanted With a Trifecta Valve | |
| Arm/Group Description | Subjects enrolled in this clinical study received the Trifecta valve during the investigational study that was conducted to obtain FDA approval. The Trifecta™ is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position. | |
All Cause Mortality |
||
| Subjects Previously Implanted With a Trifecta Valve | ||
| Affected / at Risk (%) | # Events | |
| Total | 67/329 (20.4%) | |
Serious Adverse Events |
||
| Subjects Previously Implanted With a Trifecta Valve | ||
| Affected / at Risk (%) | # Events | |
| Total | 272/329 (82.7%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 8/329 (2.4%) | 10 |
| Leukocytosis | 3/329 (0.9%) | 3 |
| Major Bleeding | 42/329 (12.8%) | 44 |
| Thrombocytopenia | 3/329 (0.9%) | 3 |
| Hyponatremia | 1/329 (0.3%) | 1 |
| Hyperkalemia | 1/329 (0.3%) | 1 |
| Minor Bleeding | 1/329 (0.3%) | 1 |
| Cardiac disorders | ||
| Cardiac Arrhythmias | 93/329 (28.3%) | 122 |
| Endocarditis | 5/329 (1.5%) | 5 |
| Heart Failure Signs and Symptoms | 34/329 (10.3%) | 46 |
| Mitral Regurgitation | 4/329 (1.2%) | 4 |
| Myocardial Ischemia | 26/329 (7.9%) | 29 |
| Paravalvular Leak | 3/329 (0.9%) | 3 |
| Pericardial Effusion | 3/329 (0.9%) | 3 |
| Pericarditis | 1/329 (0.3%) | 1 |
| Structural Valve Deterioration, Explanted | 31/329 (9.4%) | 31 |
| Structural Valve Deterioration, Transcatheter Valve-in-Valve Implant | 34/329 (10.3%) | 34 |
| Structural Valve Deterioration without Reintervention | 19/329 (5.8%) | 19 |
| Valve Thrombosis | 1/329 (0.3%) | 1 |
| Endocrine disorders | ||
| Diabetic Hyperglycemia | 1/329 (0.3%) | 1 |
| Thyroid Disorders | 2/329 (0.6%) | 3 |
| Eye disorders | ||
| Eye Disorders | 4/329 (1.2%) | 4 |
| Gastrointestinal disorders | ||
| Abdominal Hernias | 7/329 (2.1%) | 7 |
| Appendicitis | 3/329 (0.9%) | 5 |
| Esophageal Disorders | 5/329 (1.5%) | 5 |
| Vomiting, Diarrhea, Constipation | 13/329 (4%) | 16 |
| Intestinal Disorders | 10/329 (3%) | 12 |
| General disorders | ||
| Death from Unknown Causes | 8/329 (2.4%) | 8 |
| Dehydration | 3/329 (0.9%) | 3 |
| Dizziness | 7/329 (2.1%) | 7 |
| Fatigue | 2/329 (0.6%) | 2 |
| Headache | 2/329 (0.6%) | 2 |
| Heat Stroke | 1/329 (0.3%) | 1 |
| Hematoma | 4/329 (1.2%) | 4 |
| Event Classification Unknown | 2/329 (0.6%) | 2 |
| Hepatobiliary disorders | ||
| Biliary Obstruction | 1/329 (0.3%) | 1 |
| Cholecystitis | 9/329 (2.7%) | 10 |
| Infections and infestations | ||
| Bacteremia or Septicemia | 5/329 (1.5%) | 5 |
| Lower Respiratory Tract And Lung Infections | 24/329 (7.3%) | 31 |
| Wound Infections | 20/329 (6.1%) | 20 |
| Abdominal Abscess | 2/329 (0.6%) | 2 |
| Clostridium Difficile Infection | 4/329 (1.2%) | 4 |
| Foot Abscess | 1/329 (0.3%) | 1 |
| Klebsiella Infections | 1/329 (0.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Joint Disorders | 55/329 (16.7%) | 77 |
| Fractures | 8/329 (2.4%) | 9 |
| Tendon, Ligament and Cartilage Disorders | 2/329 (0.6%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Benign Lesions | 2/329 (0.6%) | 2 |
| Malignancies | 28/329 (8.5%) | 33 |
| Nervous system disorders | ||
| Delerium | 17/329 (5.2%) | 17 |
| Siezure Disorders | 4/329 (1.2%) | 5 |
| Concussion | 2/329 (0.6%) | 2 |
| Confusion | 1/329 (0.3%) | 1 |
| Guillain-Barré Syndrome | 1/329 (0.3%) | 1 |
| Peripheral Neuropathy | 1/329 (0.3%) | 1 |
| Encephalopathy | 1/329 (0.3%) | 1 |
| Tremor | 1/329 (0.3%) | 1 |
| Psychiatric disorders | ||
| Psychiatric Disorders | 2/329 (0.6%) | 2 |
| Renal and urinary disorders | ||
| Renal Disorders | 15/329 (4.6%) | 16 |
| Urinary Tract Disorders | 24/329 (7.3%) | 27 |
| Reproductive system and breast disorders | ||
| Reproductive System and Breast Disorders | 7/329 (2.1%) | 8 |
| Respiratory, thoracic and mediastinal disorders | ||
| Pleural Effusion | 17/329 (5.2%) | 19 |
| Pneumothorax | 3/329 (0.9%) | 3 |
| Pulmonary Edema | 4/329 (1.2%) | 4 |
| Respiratory Failure | 5/329 (1.5%) | 5 |
| Respiratory Tract Signs and Symptoms | 4/329 (1.2%) | 4 |
| Chronic Respiratory Disease | 1/329 (0.3%) | 1 |
| Barotrauma | 1/329 (0.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Cellulitis | 6/329 (1.8%) | 6 |
| Lacerations or Contusions | 3/329 (0.9%) | 3 |
| Rashes, Eruptions And Exanthems | 2/329 (0.6%) | 2 |
| Vascular disorders | ||
| Aortic Artery Disease | 2/329 (0.6%) | 2 |
| Carotid Artery Disease | 4/329 (1.2%) | 4 |
| Deep Vein Thrombosis | 8/329 (2.4%) | 9 |
| Hypertension | 5/329 (1.5%) | 5 |
| Hypotension | 1/329 (0.3%) | 1 |
| Peripheral Arterial Disease | 9/329 (2.7%) | 13 |
| Thromboembolism | 19/329 (5.8%) | 21 |
| Air Embolism | 1/329 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Subjects Previously Implanted With a Trifecta Valve | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Clinical Scientist, Tissue Heart Valves |
|---|---|
| Organization | Abbott Medical Devices, Structural Heart Divison |
| Phone | +1 651-756-2320 |
| Roland.MaudeGriffin@Abbott.com |
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