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An Observational, Prospective Evaluation of the Trifecta™ Valve

NCT00727181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-02-04

No results posted yet for this study

Summary

This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.

Conditions

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

Interventions

DEVICE

Trifecta aortic heart valve

Replacement of a diseased, damaged, or malfunctioning aortic heart valve

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Friedrich W Mohr, MD · Universitat Herzzentrum Leipzig GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • France
  • Germany
  • Netherlands

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 NCT00727181 on ClinicalTrials.gov