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DurAVR™ THV EU-EFS

NCT06510855 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-04

No results posted yet for this study

Summary

A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves.

Conditions

  • Symptomatic Aortic Stenosis
  • Severe Aortic Valve Stenosis
  • Aortic Valve Calcification
  • Aortic Valve Failure
  • Aortic Valve Disease

Interventions

DEVICE

DurAVR™ THV System

DurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure

Sponsors & Collaborators

  • Anteris Technologies Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-21
Primary Completion
2026-07-31
Completion
2031-08-31

Countries

  • Denmark

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 NCT06510855 on ClinicalTrials.gov