N/A
Completed N=329
Trifecta™ Long Term Follow-Up (LTFU) Study
Aortic Valve Insufficiency · Aortic Valve Regurgitation · Aortic Valve Stenosis · Aortic Valve Incompetence
Source: ClinicalTrials.gov NCT01593917 ↗
Enrolled (actual)
329
Serious AEs
82.7%
Results posted
Feb 2021
Primary outcomePrimary: Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant — 75.7 Percentage of Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant |
75.7 | — |
| SECONDARY Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant |
77.1 | — |
| SECONDARY Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant |
98.4 | — |
| SECONDARY Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant |
68.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Patient is currently participating or planning to participate in any other study unless approved by the Sponsor.
Data sourced from ClinicalTrials.gov (NCT01593917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.