NCT01593917

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2012

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2019

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 1, 2021

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

7.2 years

First QC Date

May 4, 2012

Results QC Date

December 9, 2020

Last Update Submit

February 7, 2025

Conditions

Aortic Valve InsufficiencyAortic Valve RegurgitationAortic Valve StenosisAortic Valve Incompetence

Keywords

Aortic valveHeart valveTissue valveBioprosthesis

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 years post-implant

Secondary Outcomes (3)

  • Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant

    10 years post-implant

  • Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant

    10 years post-implant

  • Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant

    10 years post-implant

Other Outcomes (5)

  • Number of Late Adverse Events Per 100 Patient-Years of Follow-up

    31 days through 10 years post-implant

  • Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size

    10 years post-implant

  • Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size

    10 years post-implant

  • +2 more other outcomes

Study Arms (1)

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

Interventions

Trifecta™ ValveDEVICE

Aortic valve replacement with the Trifecta™ aortic bioprosthesis.

Subjects previously implanted with a Trifecta™ valve in the Trifecta™ IDE Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects previously implanted with a Trifecta prosthetic valve

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

USC University Hospital

Los Angeles, California, 90033, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mission Health & Hospitals

Asheville, North Carolina, 28801, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Main Line Health Center/Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Intermountain Salt Lake Cardiovascular and Thoracic Surgery

Salt Lake City, Utah, 84103, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Institut de Cardiologie de Quebec (Hôpital Laval)

Québec, G1V 4G5, Canada

Location

Related Publications (2)

  • 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.

    PMID: 23477687BACKGROUND

  • 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.

    PMID: 27964975BACKGROUND

MeSH Terms

Conditions

Aortic Valve InsufficiencyAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Results Point of Contact

Title
Clinical Scientist, Tissue Heart Valves
Organization
Abbott Medical Devices, Structural Heart Divison
Roland.MaudeGriffin@Abbott.com
+1 651-756-2320

Study Officials

  • Barathi Sethuraman

    Abbott Structural Heart

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 8, 2012

Study Start

July 2, 2012

Primary Completion

September 26, 2019

Study Completion

September 26, 2019

Last Updated

February 11, 2025

Results First Posted

February 1, 2021

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)US(9)