Trifecta™ Long Term Follow-Up (LTFU) Study

NCT ID: NCT01593917

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 329 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-02
• Study Completion Date: 2019-09-26

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Trifecta™ Valve

Intervention Type: DEVICE

Aortic valve replacement with the Trifecta™ aortic bioprosthesis.

Interventions

Trifecta™ Valve

Aortic valve replacement with the Trifecta™ aortic bioprosthesis.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patient met eligibility criteria prior to enrollment in the Trifecta™ IDE study.

3. Patient agrees to complete all required follow-up visits.

4. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barathi Sethuraman

Role: STUDY_DIRECTOR

Abbott Structural Heart

Locations

USC University Hospital

Los Angeles, California, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Mission Health & Hospitals

Asheville, North Carolina, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Main Line Health Center/Lankenau Hospital

Wynnewood, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Intermountain Salt Lake Cardiovascular and Thoracic Surgery

Salt Lake City, Utah, United States

St. Paul's Hospital

Vancouver, British Columbia, Canada

Institut de Cardiologie de Quebec (Hôpital Laval)

Québec, , Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 23477687 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27964975 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1104

Identifier Type: -

Identifier Source: org_study_id