Trifecta™ Long Term Follow-Up (LTFU) Study

Completed

Conditions studied: Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence

In brief

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.

Key facts

Study ID: NCT01593917
Run by: Abbott Medical Devices
People needed: 329
Starts: 2012-07-02
Expected to finish: 2019-09-26
Last updated by the study team: 2025-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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 (HÃ´pital Laval) — Québec, Canada

Full record on ClinicalTrials.gov

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