An Observational, Prospective Evaluation of the Trifecta™ Valve

Status Completed

Clinical Trial 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.

Clinical Trial Description

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study without concurrent or matched controls, designed to evaluate the safety and effectiveness of the Trifecta valve. A maximum of 120 subjects requiring aortic valve replacement will be implanted at a maximum of 6 investigational sites in Europe. The sample size is based on late patient-years of follow-up with a minimum of 400 late patient-years experience required. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00727181
Study type	Interventional
Source	Abbott Medical Devices
Contact
Status	Completed
Phase	N/A
Start date	November 2007
Completion date	December 2010

View Details

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