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Trifecta™ Durability Study

NCT01256710 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1151

Last updated 2023-11-22

Study results available
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Summary

The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve. The Trifecta™ valve is a stented surgical aortic bioprosthesis with bovine pericardial leaflets designed for supra annular placement.

Conditions

  • Aortic Valve Disease

Interventions

DEVICE

Trifecta™ aortic bioprosthesis

Surgical aortic valve replacement with the Trifecta™ valve.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Sven Lehmann · Universitat Herzzentrum Leipzig

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2021-03-12
Completion
2021-03-12

Countries

  • Germany

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 NCT01256710 on ClinicalTrials.gov