NCT05478161

Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis

Investigation of the Safety and Performance of the NVT ALLEGRA THV System With a New Delivery System in Patients With Severe Calcified Aortic Stenosis or Failed Surgical Aortic Bioprosthesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: NVT GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System. The primary endpoint is device success rate at 7 days (discharge from index procedure or 7 days post implant, whichever comes first), as defined by VARC 2. Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 107 patients need to be enrolled in the study.

Conditions

• Transcatheter Aortic Valve Implantation

Interventions

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

Timeline

• Start date: 2023-01-24
• Primary completion: 2023-12-20
• Completion: 2024-12-17
• First posted: 2022-07-28
• Last updated: 2026-02-24

Locations

11 sites across 3 countries: Germany, Netherlands, Spain