DurAVR™ THV EU-EFS

April 28, 2026 updated by: Anteris Technologies Ltd.

DurAVR™ THV System: European Early Feasibility Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The DurAVR™ THV System is a novel balloon-expandable single-piece transcatheter aortic valve.

The study will enroll up to 40 subjects with severe, symptomatic native aortic stenosis or with severe degeneration of surgically implanted aortic bioprosthetic valves, with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.

Subjects will be consented for follow-up to 5 years.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region of Denmark
      • Copenhagen, Capital Region of Denmark, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older.
  2. Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team
  3. Eligible for transfemoral delivery of the DurAVR™ THV
  4. Anatomy appropriate to accommodate safe placement of DurAVR™ THV
  5. Understands the study requirements and the treatment procedures and provides written informed consent
  6. Subject agrees to complete all required scheduled follow-up visits.

Exclusion Criteria:

  1. Anatomy precluding safe placement of DurAVR™ THV
  2. Pre-existing prosthetic mitral or tricuspid valve
  3. Unicuspid, bicuspid or non-calcified aortic valve
  4. Severe mitral or severe tricuspid regurgitation requiring intervention
  5. Moderate to severe mitral stenosis
  6. Hypertrophic obstructive cardiomyopathy
  7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
  8. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
  9. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
  10. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  11. End-stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min
  12. GI bleeding within the past 3 months
  13. Ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months
  14. Life expectancy < 12 months due to associated non-cardiac co-morbid conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Severe Aortic Stenosis (sAS) Cohort
Subjects with symptomatic severe native aortic stenosis with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.
Device: DurAVR™ THV System
DurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure
Experimental: Failed Surgical Aortic Bioprosthetic Valve (FAV) Cohort
Subjects with severe degeneration of surgically implanted aortic bioprosthetic valves with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.
Device: DurAVR™ THV System
DurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality or disabling stroke
Time Frame: 30 Days
Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 30 Days
Mortality would be reported as rate of death/mortality at 30 days.
30 Days
Disabling stroke
Time Frame: 30 Days
Disabling stroke would be reported according to VARC-3 Guidelines
30 Days
Life-threatening bleeding
Time Frame: 30 Days
Life-threatening bleeding according to VARC-3 Guidelines
30 Days
Major vascular, access-related, or cardiac structural complication
Time Frame: 30 Days
Major vascular, access-related, or cardiac structural complication according to VARC-3 Guidelines
30 Days
Acute kidney injury stage 3 or 4
Time Frame: 30 Days
AKI according to VARC-3 Guidelines
30 Days
Moderate or severe aortic regurgitation
Time Frame: 30 Days
Aortic regurgitation according to VARC-3 Guidelines
30 Days
New permanent pacemaker due to procedure related conduction abnormalities
Time Frame: 30 Days
Rate of pacemaker interventions in subjects experiencing conduction abnormalities (sAS cohort only)
30 Days
Surgery or intervention related to the device, including aortic valve reintervention
Time Frame: 30 Days
Device related interventions
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anteris Technologies Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2031

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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