clinical trial · NCT05804903
Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
NVT GmbH·N/A·suspended·n = 177
Transcatheter Aortic Valve Implantation(ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
brief 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.
started
Nov 24, 2023
primary completion
Aug 31, 2025
completion
Aug 1, 2030
last updated
Mar 9, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol