Trifecta™ Long Term Follow-Up (LTFU) Study

Abbott

Status: Completed

Conditions: Aortic Valve Stenosis; Aortic Valve Regurgitation; Aortic Valve Insufficiency; Aortic Valve Incompetence

Treatments: Device: Trifecta™ Valve

Study type: Observational

Funder types: Industry

Identifiers

NCT01593917

1104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 329 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

329 participants in 1 patient group

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

Description:

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.

Treatment:

Device: Trifecta™ Valve