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

NCT05804903 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2026-03-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • NVT GmbH

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-24
Primary Completion
2025-08-31
Completion
2030-08-01

Countries

  • Finland
  • Germany
  • Poland
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05804903 on ClinicalTrials.gov