DurAVR™ THV System for Aortic Stenosis

(DurAVR™ EFS Trial)

Recruiting at 6 trial locations

Overseen By Ioana Ghiu, MD MS

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Anteris Technologies Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?

To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.

Research Team

Michael Reardon, MD

Principal Investigator

Methodist DeBakey Hospital

Eligibility Criteria

This trial is for people aged 65 or older with severe aortic stenosis who have symptoms and need valve replacement. They must understand the study, agree to follow-ups, be suitable for transfemoral DurAVR™ THV delivery, and have an appropriate heart anatomy. Exclusions include inoperability, participation in other trials, certain vulnerable groups, various heart conditions like unicuspid/bicuspid valves or recent infarctions, blood disorders, untreated significant coronary disease, shock states or severe organ dysfunction.

Inclusion Criteria

I am over 65 and have severe symptoms from aortic valve narrowing.

Your heart anatomy can safely fit the DurAVR™ THV, as measured by TTE and CT scans showing aortic annulus diameter of 21-23 mm.

Able to have the DurAVR™ THV inserted through the leg artery.

Exclusion Criteria

Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention)

You have an artificial heart valve.

I do not have severe dementia that affects my daily independence or ability to follow treatment.

Treatment Details

Interventions

• DurAVR™ THV System (Transcatheter Aortic Valve Replacement (TAVR))

Trial Overview The trial tests the safety and feasibility of the DurAVR™ THV System for treating symptomatic severe native aortic stenosis. It involves replacing the patient's aortic valve using this system through a transfemoral approach (via the femoral artery).

Participant Groups

Group I: DurAVR™ THV System Experimental Treatment 1 Intervention

TAVR procedure

Who Is Running the Clinical Trial?

Anteris Technologies Ltd.

Lead Sponsor

Trials

6

Recruited

160+

Admedus Regen Pty Ltd.

Lead Sponsor

Trials

7

Recruited

420+