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

NCT05478161 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2026-02-24

No results posted yet for this study

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

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

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
2023-01-24
Primary Completion
2023-12-20
Completion
2024-12-17

Countries

  • Germany
  • Netherlands
  • Spain

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 NCT05478161 on ClinicalTrials.gov