NCT01808274

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 19 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 patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

Detailed description

This is a non-randomized, prospective, multi-center safety and device success study. 34 patients have been enrolled at 4 participating investigational centers in Europe. 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: 2013-02-01
• Primary completion: 2013-09-17
• Completion: 2018-08-23
• First posted: 2013-03-11
• Last updated: 2018-11-20

Locations

4 sites across 2 countries: Germany, Switzerland