New heart valve device shows early promise in small study

NCT ID NCT06510855

Disease control Sponsor: Anteris Technologies Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This early study is testing a new device called the DurAVR™ THV System, which is a replacement heart valve placed through a small tube in the leg (TAVI procedure). The study includes 40 people with severe aortic stenosis or a failed surgical valve. The main goal is to see if the device is safe and feasible, looking at rates of death or disabling stroke at 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: DurAVR™ THV System (a replacement heart valve implanted via a catheter)
What this could lead to: If this device works well, it could offer a new, less invasive option for people with severe aortic stenosis who need a valve replacement.
What could go wrong: This is a very early, small study (40 people) focused on safety and feasibility. The device may not work as well as existing valves, and there are risks like bleeding, stroke, or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

15 people

The number who actually took part.

Started

Jan 2025

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic valve calcification Aortic Valve Disease aortic valve disorder aortic valve insufficiency aortic valve stenosis Aortic Valve, Calcification of

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve calcification Aortic valve disease Aortic valve failure Severe aortic valve stenosis Symptomatic aortic stenosis

New heart valve device shows early promise in small study

What the study statuses mean