NCT01445171

Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 295 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.

Detailed description

This is a two-phase, non-randomized, prospective, single arm, multi-center clinical investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per subject.

Conditions

• Aortic Valve Stenosis With Insufficiency
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Aortic Valve Replacement with EDWARDS INTUITY Valve System	Aortic Valve bioprosthesis

Timeline

• Start date: 2010-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2011-10-03
• Last updated: 2023-09-01
• Results posted: 2020-02-17

Locations

6 sites across 2 countries: Austria, Germany

Regulatory

• FDA-regulated device study