NCT00727181

An Observational, Prospective Evaluation of the Trifecta™ Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Trifecta aortic heart valve	Replacement of a diseased, damaged, or malfunctioning aortic heart valve

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2008-08-01
• Last updated: 2019-02-04

Locations

4 sites across 3 countries: France, Germany, Netherlands