Trial Outcomes & Findings for Trifecta™ Long Term Follow-Up (LTFU) Study (NCT NCT01593917)

Last Updated: 2025-02-11

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

329 participants

Primary outcome timeframe

10 years post-implant

Results posted on

2025-02-11

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Subjects Previously Implanted With a Trifecta™ Valve Subjects enrolled in this clinical study received the Trifecta™ valve during the Trifecta™ IDE Study conducted to obtain FDA approval.
Overall Study STARTED	329
Overall Study COMPLETED	159
Overall Study NOT COMPLETED	170

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects Previously Implanted With a Trifecta™ Valve Subjects enrolled in this clinical study received the Trifecta™ valve during the Trifecta™ IDE Study conducted to obtain FDA approval.
Overall Study Death	67
Overall Study Valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) or Surgical Explant	60
Overall Study Withdrawal by Subject	23
Overall Study Lost to Follow-up	12
Overall Study Protocol Violation	5
Overall Study Physician Decision	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Previously Implanted With a Trifecta™ Valve n=329 Participants 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.
Age, Continuous	69.7 years STANDARD_DEVIATION 8.9 • n=329 Participants
Sex: Female, Male Female	105 Participants n=329 Participants
Sex: Female, Male Male	224 Participants n=329 Participants
Region of Enrollment Canada	102 participants n=329 Participants
Region of Enrollment United States	227 participants n=329 Participants
Preoperative New York Heart Association (NYHA) functional classification III or IV	140 Participants n=329 Participants
History of Coronary Artery Disease	180 Participants n=329 Participants
History of Hypertension	260 Participants n=329 Participants
History of Diabetes	80 Participants n=329 Participants
History of Smoking	188 Participants n=329 Participants
Preoperative Coumarin Derivatives	33 Participants n=329 Participants
Preoperative Aspirin	228 Participants n=329 Participants
Preoperative Antiplatelet Medication	24 Participants n=329 Participants
Previous Cardiovascular Surgery/Procedure	85 Participants n=329 Participants
No Concomitant Procedure	160 Participants n=329 Participants
Concomitant Coronary Artery Bypass Grafting (CABG)	104 Participants n=329 Participants
Cardiopulmonary Bypass Time (minutes)	103.8 minutes STANDARD_DEVIATION 44.8 • n=329 Participants
Aortic Cross Clamp Time (minutes)	78.7 minutes STANDARD_DEVIATION 34 • n=329 Participants
Implanted Valve Size 19 mm	22 Participants n=329 Participants
Implanted Valve Size 21 mm	78 Participants n=329 Participants
Implanted Valve Size 23 mm	113 Participants n=329 Participants
Implanted Valve Size 25 mm	86 Participants n=329 Participants
Implanted Valve Size 27 mm	24 Participants n=329 Participants
Implanted Valve Size 29 mm	6 Participants n=329 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subjects Previously Implanted With a Trifecta™ Valve n=329 Participants Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant	75.7 Percentage of Participants Interval 70.0 to 80.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Subjects Previously Implanted With a Trifecta™ Valve n=329 Participants Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant	77.1 Percentage of Participants Interval 71.6 to 81.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Subjects Previously Implanted With a Trifecta™ Valve n=329 Participants Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant	98.4 Percentage of Participants Interval 95.7 to 99.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Subjects Previously Implanted With a Trifecta™ Valve n=329 Participants Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant	68.4 Percentage of Participants Interval 62.1 to 73.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Subjects Previously Implanted With a Trifecta™ Valve n=329 Participants Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
Number of Late Adverse Events Per 100 Patient-Years of Follow-up All-Cause Mortality	2.34 Number of events per 100 patient-years
Number of Late Adverse Events Per 100 Patient-Years of Follow-up Valve-Related Mortality	0.17 Number of events per 100 patient-years
Number of Late Adverse Events Per 100 Patient-Years of Follow-up Thromboembolism	0.52 Number of events per 100 patient-years
Number of Late Adverse Events Per 100 Patient-Years of Follow-up Valve Thrombosis	0.03 Number of events per 100 patient-years
Number of Late Adverse Events Per 100 Patient-Years of Follow-up Major Bleeding	1.05 Number of events per 100 patient-years
Number of Late Adverse Events Per 100 Patient-Years of Follow-up Major Paravalvular Leak	0.00 Number of events per 100 patient-years
Number of Late Adverse Events Per 100 Patient-Years of Follow-up Endocarditis	0.17 Number of events per 100 patient-years
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
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

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Subjects Previously Implanted With a Trifecta™ Valve n=155 Participants Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size 19 mm	24.9 mmHg Standard Deviation 12.4
Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size 21 mm	17.7 mmHg Standard Deviation 8.3
Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size 23 mm	16.0 mmHg Standard Deviation 9.1
Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size 25 mm	13.2 mmHg Standard Deviation 12.4
Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size 27 mm	8.7 mmHg Standard Deviation 5.7
Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size 29 mm	11.0 mmHg Standard Deviation 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Subjects Previously Implanted With a Trifecta™ Valve n=151 Participants Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
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
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
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
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
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
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

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subjects Previously Implanted With a Trifecta™ Valve n=155 Participants Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant None	60 Participants
Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant Trivial	53 Participants
Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant Mild	30 Participants
Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant Moderate	12 Participants
Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant Severe	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subjects Previously Implanted With a Trifecta™ Valve n=329 Participants Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant Preoperative · NYHA Class I	23 Participants
Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant Preoperative · NYHA Class II	166 Participants
Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant Preoperative · NYHA Class IV	7 Participants
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
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
Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant Preoperative · NYHA Class III	133 Participants
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
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

Adverse Events

Subjects Previously Implanted With a Trifecta Valve

Serious events: 272 serious events

Other events: 0 other events

Deaths: 67 deaths

Serious adverse events

Serious adverse events
Measure	Subjects Previously Implanted With a Trifecta Valve n=329 participants at risk 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.
Blood and lymphatic system disorders Anemia	2.4% 8/329 • Number of events 10 • 10 Years 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.
Blood and lymphatic system disorders Leukocytosis	0.91% 3/329 • Number of events 3 • 10 Years 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.
Blood and lymphatic system disorders Major Bleeding	12.8% 42/329 • Number of events 44 • 10 Years 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.
Blood and lymphatic system disorders Thrombocytopenia	0.91% 3/329 • Number of events 3 • 10 Years 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.
Blood and lymphatic system disorders Hyponatremia	0.30% 1/329 • Number of events 1 • 10 Years 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.
Cardiac disorders Cardiac Arrhythmias	28.3% 93/329 • Number of events 122 • 10 Years 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.
Cardiac disorders Endocarditis	1.5% 5/329 • Number of events 5 • 10 Years 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.
Cardiac disorders Heart Failure Signs and Symptoms	10.3% 34/329 • Number of events 46 • 10 Years 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.
Cardiac disorders Mitral Regurgitation	1.2% 4/329 • Number of events 4 • 10 Years 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.
Cardiac disorders Myocardial Ischemia	7.9% 26/329 • Number of events 29 • 10 Years 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.
Cardiac disorders Paravalvular Leak	0.91% 3/329 • Number of events 3 • 10 Years 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.
Cardiac disorders Pericardial Effusion	0.91% 3/329 • Number of events 3 • 10 Years 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.
Cardiac disorders Pericarditis	0.30% 1/329 • Number of events 1 • 10 Years 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.
Cardiac disorders Structural Valve Deterioration, Explanted	9.4% 31/329 • Number of events 31 • 10 Years 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.
Cardiac disorders Structural Valve Deterioration, Transcatheter Valve-in-Valve Implant	10.3% 34/329 • Number of events 34 • 10 Years 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.
Cardiac disorders Structural Valve Deterioration without Reintervention	5.8% 19/329 • Number of events 19 • 10 Years 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.
Cardiac disorders Valve Thrombosis	0.30% 1/329 • Number of events 1 • 10 Years 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.
Endocrine disorders Diabetic Hyperglycemia	0.30% 1/329 • Number of events 1 • 10 Years 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.
Endocrine disorders Thyroid Disorders	0.61% 2/329 • Number of events 3 • 10 Years 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.
Eye disorders Eye Disorders	1.2% 4/329 • Number of events 4 • 10 Years 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.
Gastrointestinal disorders Abdominal Hernias	2.1% 7/329 • Number of events 7 • 10 Years 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.
Gastrointestinal disorders Appendicitis	0.91% 3/329 • Number of events 5 • 10 Years 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.
Gastrointestinal disorders Esophageal Disorders	1.5% 5/329 • Number of events 5 • 10 Years 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.
Gastrointestinal disorders Vomiting, Diarrhea, Constipation	4.0% 13/329 • Number of events 16 • 10 Years 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.
Gastrointestinal disorders Intestinal Disorders	3.0% 10/329 • Number of events 12 • 10 Years 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.
General disorders Death from Unknown Causes	2.4% 8/329 • Number of events 8 • 10 Years 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.
General disorders Dehydration	0.91% 3/329 • Number of events 3 • 10 Years 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.
General disorders Dizziness	2.1% 7/329 • Number of events 7 • 10 Years 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.
General disorders Fatigue	0.61% 2/329 • Number of events 2 • 10 Years 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.
General disorders Headache	0.61% 2/329 • Number of events 2 • 10 Years 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.
General disorders Heat Stroke	0.30% 1/329 • Number of events 1 • 10 Years 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.
General disorders Hematoma	1.2% 4/329 • Number of events 4 • 10 Years 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.
General disorders Event Classification Unknown	0.61% 2/329 • Number of events 2 • 10 Years 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.
Hepatobiliary disorders Biliary Obstruction	0.30% 1/329 • Number of events 1 • 10 Years 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.
Hepatobiliary disorders Cholecystitis	2.7% 9/329 • Number of events 10 • 10 Years 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.
Infections and infestations Bacteremia or Septicemia	1.5% 5/329 • Number of events 5 • 10 Years 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.
Infections and infestations Lower Respiratory Tract And Lung Infections	7.3% 24/329 • Number of events 31 • 10 Years 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.
Infections and infestations Wound Infections	6.1% 20/329 • Number of events 20 • 10 Years 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.
Infections and infestations Abdominal Abscess	0.61% 2/329 • Number of events 2 • 10 Years 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.
Musculoskeletal and connective tissue disorders Joint Disorders	16.7% 55/329 • Number of events 77 • 10 Years 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Lesions	0.61% 2/329 • Number of events 2 • 10 Years 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignancies	8.5% 28/329 • Number of events 33 • 10 Years 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.
Nervous system disorders Delerium	5.2% 17/329 • Number of events 17 • 10 Years 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.
Nervous system disorders Siezure Disorders	1.2% 4/329 • Number of events 5 • 10 Years 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.
Nervous system disorders Concussion	0.61% 2/329 • Number of events 2 • 10 Years 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.
Psychiatric disorders Psychiatric Disorders	0.61% 2/329 • Number of events 2 • 10 Years 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.
Renal and urinary disorders Renal Disorders	4.6% 15/329 • Number of events 16 • 10 Years 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.
Renal and urinary disorders Urinary Tract Disorders	7.3% 24/329 • Number of events 27 • 10 Years 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.
Reproductive system and breast disorders Reproductive System and Breast Disorders	2.1% 7/329 • Number of events 8 • 10 Years 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.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	5.2% 17/329 • Number of events 19 • 10 Years 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.91% 3/329 • Number of events 3 • 10 Years 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.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	1.2% 4/329 • Number of events 4 • 10 Years 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.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.5% 5/329 • Number of events 5 • 10 Years 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.
Skin and subcutaneous tissue disorders Cellulitis	1.8% 6/329 • Number of events 6 • 10 Years 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.
Skin and subcutaneous tissue disorders Lacerations or Contusions	0.91% 3/329 • Number of events 3 • 10 Years 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.
Skin and subcutaneous tissue disorders Rashes, Eruptions And Exanthems	0.61% 2/329 • Number of events 2 • 10 Years 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.
Vascular disorders Aortic Artery Disease	0.61% 2/329 • Number of events 2 • 10 Years 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.
Vascular disorders Carotid Artery Disease	1.2% 4/329 • Number of events 4 • 10 Years 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.
Vascular disorders Deep Vein Thrombosis	2.4% 8/329 • Number of events 9 • 10 Years 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.
Vascular disorders Hypertension	1.5% 5/329 • Number of events 5 • 10 Years 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.
Vascular disorders Hypotension	0.30% 1/329 • Number of events 1 • 10 Years 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.
Vascular disorders Peripheral Arterial Disease	2.7% 9/329 • Number of events 13 • 10 Years 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.
Vascular disorders Thromboembolism	5.8% 19/329 • Number of events 21 • 10 Years 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.
Blood and lymphatic system disorders Hyperkalemia	0.30% 1/329 • Number of events 1 • 10 Years 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.
Vascular disorders Air Embolism	0.30% 1/329 • Number of events 1 • 10 Years 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.
Blood and lymphatic system disorders Minor Bleeding	0.30% 1/329 • Number of events 1 • 10 Years 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.
Infections and infestations Clostridium Difficile Infection	1.2% 4/329 • Number of events 4 • 10 Years 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.
Infections and infestations Foot Abscess	0.30% 1/329 • Number of events 1 • 10 Years 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.
Infections and infestations Klebsiella Infections	0.30% 1/329 • Number of events 1 • 10 Years 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.
Musculoskeletal and connective tissue disorders Fractures	2.4% 8/329 • Number of events 9 • 10 Years 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.
Musculoskeletal and connective tissue disorders Tendon, Ligament and Cartilage Disorders	0.61% 2/329 • Number of events 2 • 10 Years 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.
Nervous system disorders Confusion	0.30% 1/329 • Number of events 1 • 10 Years 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.
Nervous system disorders Guillain-Barré Syndrome	0.30% 1/329 • Number of events 1 • 10 Years 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.
Nervous system disorders Peripheral Neuropathy	0.30% 1/329 • Number of events 1 • 10 Years 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.
Nervous system disorders Encephalopathy	0.30% 1/329 • Number of events 1 • 10 Years 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.
Nervous system disorders Tremor	0.30% 1/329 • Number of events 1 • 10 Years 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.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Signs and Symptoms	1.2% 4/329 • Number of events 4 • 10 Years 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.
Respiratory, thoracic and mediastinal disorders Chronic Respiratory Disease	0.30% 1/329 • Number of events 1 • 10 Years 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.
Respiratory, thoracic and mediastinal disorders Barotrauma	0.30% 1/329 • Number of events 1 • 10 Years 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.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Scientist, Tissue Heart Valves

Abbott Medical Devices, Structural Heart Divison

Phone: +1 651-756-2320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place