Aortic Valve InsufficiencyNCT01593917

Trifecta™ Long Term Follow-Up (LTFU) Study

An observational study of Aortic Valve Insufficiency and Aortic Valve Regurgitation, run by Abbott Medical Devices at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis
What is being tested?: Trifecta™ Valve
Type of treatment: Medical device
How many people: 329 participants
Where: 11 sitesin 2 countries
Study dates: 2 Jul 2012to 26 Sep 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects previously implanted with a Trifecta prosthetic valve

Who may be able to join

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.

Who cannot join

1. Patient is currently participating or planning to participate in any other study unless approved by the Sponsor.

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States9 sites

Mission Health & Hospitals
Asheville, North Carolina, 28801
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
USC University Hospital
Los Angeles, California, 90033
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Intermountain Salt Lake Cardiovascular and Thoracic Surgery
Salt Lake City, Utah, 84103
Main Line Health Center/Lankenau Hospital
Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada2 sites

Institut de Cardiologie de Quebec (HÃ´pital Laval)
Québec, G1V 4G5
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: Long Term Follow Up Study of the St. Jude Medical Trifecta™ Valve

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.

Read the 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.

Conditions: Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
Being tested: Trifecta™ Valve
Keywords: Aortic valve, Heart valve, Tissue valve, Bioprosthesis
Medical subject headings: Aortic Valve Insufficiency, Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trifecta™ ValveDevice
Aortic valve replacement with the Trifecta™ aortic bioprosthesis.

Study groups in NCT01593917
Study group	Role	What they receive
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. Receives: Device: Trifecta™ Valve

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant
Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve implantation for treatment of structural deterioration of the Trifecta™ valve through 10 years post-implant. This percentage is estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation.
Measured: 10 years post-implant

Secondary outcomes (3)

Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant
Percentage of participants free of death from any cause through 10 years after implant with the Trifecta™ valve, estimated from time-to-event data using the Kaplan-Meier estimator.
Measured: 10 years post-implant
Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant
Percentage of participants free from death related to the Trifecta™ valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Valve-related mortality includes deaths due to any of the following events involving the study valve: structural valvular deterioration, nonstructural valve dysfunction, valve thrombosis, embolism, bleeding events, endocarditis, or reoperation. Sudden, unexplained deaths of participants implanted with the Trifecta™ valve are also counted as valve-related mortality.
Measured: 10 years post-implant
Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant
Percentage of participants free of structural deterioration of the Trifecta valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. The presence of structural valve deterioration is determined by direct visualization of the valve at explant or autopsy or by echocardiographic or other cardiac imaging criteria for assessment of valvular stenosis and regurgitation.
Measured: 10 years post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 201226 Sep 2019

First posted8 May 2012 (estimated)
Study start2 Jul 2012
Primary completion26 Sep 2019
Study completion26 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Aortic Valve InsufficiencyStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 329 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01593917
Sponsor's protocol ID: 1104
Status last verified: Feb 2025
First submitted: 4 May 2012
Last updated: 11 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 23477687
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.
PubMed 27964975

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
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The JenaValve ALIGN-AR LVAD Registry
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Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Not yet recruitingObservational study
Echocardiographic Perspectives on Transient Mitral Regurgitation After Septal Myectomy
Hypertrophic Cardiomyopathy

All Aortic Valve Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Follow Up Study of the St. Jude Medical Trifecta™ Valve
ClinicalTrials.gov ID: NCT01593917
Acronym / sponsor ID: 1104
Conditions: Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
Keywords: Aortic valve, Heart valve, Tissue valve, Bioprosthesis
Study type: Observational
Recruitment status: Completed
Enrolment: 329 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 2 Jul 2012 (actual)
Primary completion: 26 Sep 2019 (actual)
Study completion: 26 Sep 2019 (actual)
First posted: 8 May 2012 (estimated)
Results: Posted 1 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Subjects previously implanted with a Trifecta™ valve in the Trifecta™ IDE Study	–	Device: Trifecta™ ValveSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects previously implanted with a Trifecta prosthetic valve

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

1. Patient is currently participating or planning to participate in any other study unless approved by the Sponsor.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Trifecta™ ValveAortic valve replacement with the Trifecta™ aortic bioprosthesis.	Device	Subjects previously implanted with a Trifecta™ valve in the Trifecta™ IDE Study

Primary outcome

Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant
Time frame: 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.

3 secondary outcomes

Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant
Time frame: 10 years post-implant
Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant
Time frame: 10 years post-implant
Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant
Time frame: 10 years post-implant

Results and safety

Results posted to the registry on 1 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Previously Implanted With a Trifecta™ Valve	329	159

Primary outcome: Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant

Time frame: 10 years post-implant. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Subjects Previously Implanted With a Trifecta™ Valve n = 329
Value	75.7 (70.0 to 80.5)

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 Years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Previously Implanted With a Trifecta Valve	272 of 329 (82.7%)	0 of 0	67 of 329

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23477687Bavaria 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.
Background: PubMed 27964975Goldman 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.
Individual participant dataSharing planned: No

Related trials for Aortic Valve Insufficiency

Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
Active, not recruiting
The JenaValve ALIGN-AR LVAD Registry
Aortic Regurgitation, Aortic Valve Insufficiency
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Not yet recruitingObservational study
Echocardiographic Perspectives on Transient Mitral Regurgitation After Septal Myectomy
Hypertrophic Cardiomyopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barathi Sethuraman study director

Abbott Structural Heart

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Insufficiency and Aortic Valve Regurgitation, run by Abbott Medical Devices at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant (time frame: 10 years post-implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01593917, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.