- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01593917
Trifecta™ Long Term Follow-Up (LTFU) Study
Long Term Follow Up Study of the St. Jude Medical Trifecta™ Valve
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Quebec, Canada, G1V 4G5
- Institut de Cardiologie de Quebec (Hôpital Laval)
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- St. Paul's Hospital
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California
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Los Angeles, California, United States, 90033
- USC University Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Abbott Northwestern Hospital
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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North Carolina
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Asheville, North Carolina, United States, 28801
- Mission Health & Hospitals
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Ohio
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Cleveland, Ohio, United States, 44195
- The Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Wynnewood, Pennsylvania, United States, 19096
- Main Line Health Center/Lankenau Hospital
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Utah
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Salt Lake City, Utah, United States, 84103
- Intermountain Salt Lake Cardiovascular and Thoracic Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
1. Patient is currently participating or planning to participate in any other study unless approved by the Sponsor.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Aortic valve replacement with the Trifecta™ aortic bioprosthesis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant
Time Frame: 10 years post-implant
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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.
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10 years post-implant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant
Time Frame: 10 years post-implant
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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.
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10 years post-implant
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Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant
Time Frame: 10 years post-implant
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Percentage of participants free from death related to the Trifecta™ valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator.
Valve-related mortality includes deaths due to any of the following events involving the study valve: structural valvular deterioration, nonstructural valve dysfunction, valve thrombosis, embolism, bleeding events, endocarditis, or reoperation.
Sudden, unexplained deaths of participants implanted with the Trifecta™ valve are also counted as valve-related mortality.
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10 years post-implant
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Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant
Time Frame: 10 years post-implant
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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.
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10 years post-implant
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Late Adverse Events Per 100 Patient-Years of Follow-up
Time Frame: 31 days through 10 years post-implant
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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.
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31 days through 10 years post-implant
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Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size
Time Frame: 10 years post-implant
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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).
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10 years post-implant
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Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size
Time Frame: 10 years post-implant
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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.
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10 years post-implant
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Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant
Time Frame: 10 years post-implant
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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.
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10 years post-implant
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Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant
Time Frame: Preoperative through 10 years
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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. |
Preoperative through 10 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Angelic Roach, Abbott Medical Devices
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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