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Trifecta™ Long Term Follow-Up (LTFU) Study

NCT01593917 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 329

Last updated 2025-02-11

Study results available
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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.

Conditions

  • Aortic Valve Insufficiency
  • Aortic Valve Regurgitation
  • Aortic Valve Stenosis
  • Aortic Valve Incompetence

Interventions

DEVICE

Trifecta™ Valve

Aortic valve replacement with the Trifecta™ aortic bioprosthesis.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Barathi Sethuraman · Abbott Structural Heart

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-02
Primary Completion
2019-09-26
Completion
2019-09-26
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593917 on ClinicalTrials.gov