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A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System

NCT07194265 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1650

Last updated 2026-05-11

No results posted yet for this study

Summary

Prospective, randomized, controlled, multicenter, international study.

Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved Transcatheter Heart Valve (THV) from the SAPIEN series or the Evolut series and followed for 10 years.

After completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'.

Up to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.

Conditions

  • Severe Aortic Stenosis
  • Valve-in-valve Procedures

Interventions

DEVICE

TAVR with DurAVR® THV

Transcatheter aortic valve replacement (TAVR)

DEVICE

TAVR with SAPIEN THV series or the Evolut THV series

Transcatheter aortic valve replacement (TAVR)

Sponsors & Collaborators

  • Anteris Technologies Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2027-12-31
Completion
2038-03-31
FDA Device
Yes

Countries

  • United States
  • 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 NCT07194265 on ClinicalTrials.gov