NCT00475709

Aortic Valve Replacement With Trifecta(TM)

An Observational, Prospective Evaluation of the Trifecta Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,022 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To confirm the clinical safety and effectiveness of the Trifecta valve.

Detailed description

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Trifecta Aortic Heart Valve	Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-07-01
• Completion: 2012-01-01
• First posted: 2007-05-21
• Last updated: 2019-02-19
• Results posted: 2014-03-11

Locations

18 sites across 1 country: United States