NCT05804903

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

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: NVT GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transcatheter Aortic Valve Implantation

Interventions

Type	Name	Description
DEVICE	(ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis	Implantation of the ALLEGRA Plus Transcatheter Heart Valve in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis

Timeline

• Start date: 2023-11-24
• Primary completion: 2025-08-31
• Completion: 2030-08-01
• First posted: 2023-04-07
• Last updated: 2026-03-09

Locations

7 sites across 5 countries: Finland, Germany, Poland, Spain, Switzerland