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Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis — EMPIRE-II  

Transcatheter Aortic Valve Implantation Clinical Trial

Official title:
InvEstigation of the Safety and Performance of the NVT ALLEGRA Plus THV SysteM in Patients With Severe aortIc Stenosis or Failed suRgical Aortic bioprosthEsis

Clinical Trial Summary

The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System. The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months. And the primary performance endpoint is device success at 7 days. Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 177 patients need to be enrolled in the study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05804903
Study type Interventional
Source NVT GmbH
Contact Calvin Bahr
Phone +41 78 251 8084
Email c.bahr@biosensors.com
Status Recruiting
Phase N/A
Start date November 24, 2023
Completion date December 31, 2029
View Details
See also
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