NCT02458560

CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.

Detailed description

This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	Edwards CENTERA Self-Expanding Transcatheter Heart Valve	The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR).

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-08-22
• Completion: 2021-08-13
• First posted: 2015-06-01
• Last updated: 2021-10-18

Locations

27 sites across 9 countries: Australia, Denmark, France, Germany, Italy, Netherlands, New Zealand, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study