DurAVR™ THV System for Aortic Stenosis

(DurAVR™ EFS Trial)

Not currently recruiting at 7 trial locations

Overseen By Ioana Ghiu, MD MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Anteris Technologies Ltd.

Must not be taking: Aspirin, Heparin, Ticlopidine, others

Disqualifiers: Prosthetic heart valve, Severe dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Immediate post procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the DurAVR™ THV System, a new device designed to assist individuals with severe aortic stenosis, a condition where the heart's aortic valve doesn't open properly. The trial aims to determine if this device is safe and effective for those needing valve replacement. Individuals experiencing symptoms from severe aortic stenosis and suitable for a procedure called TAVR might be ideal candidates. The trial seeks participants who can undergo a new valve delivery method through the leg (transfemoral delivery) and have heart anatomy that can safely accommodate the device. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for aortic stenosis.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to aspirin, heparin, nitinol, ticlopidine, clopidogrel, or contrast media, you may need to discuss this with the trial team.

What prior data suggests that the DurAVR™ THV System is safe for treating aortic stenosis?

Research has shown that the DurAVR™ THV System demonstrates promising safety results from earlier studies. The device was successfully implanted in all cases without any device-related problems. However, complications included one issue at the access site and one instance requiring a permanent pacemaker. This indicates that while the treatment is generally well-tolerated, some risks remain. Overall, early data suggest the DurAVR™ THV System is safe for treating severe aortic stenosis (a narrowing of the heart valve), but potential side effects should be considered, as with any medical procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The DurAVR™ THV System is unique because it offers a novel approach to treating aortic stenosis through a transcatheter aortic valve replacement (TAVR) procedure. Unlike traditional surgical aortic valve replacement, which requires open-heart surgery, the DurAVR™ THV System is minimally invasive, potentially reducing recovery time and associated risks. Researchers are excited about this treatment as it combines advanced materials and design to potentially improve valve durability and performance, thus benefiting patients who might not be ideal candidates for surgery.

What evidence suggests that the DurAVR™ THV System is effective for aortic stenosis?

Research has shown that the DurAVR™ THV System, which trial participants will receive, holds promise for treating severe aortic stenosis, a condition where a heart valve narrows and restricts blood flow. One study found that after one year, patients experienced positive results, with no valve-related deaths and no major leaks around it. Another study found that blood flow through the DurAVR™ valve was similar to that of a healthy valve, suggesting the device effectively maintains smooth blood flow. Overall, the DurAVR™ THV System shows strong potential for effectively treating this heart condition. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael Reardon, MD

Principal Investigator

Methodist DeBakey Hospital

Are You a Good Fit for This Trial?

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

You have an artificial heart valve.

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)

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the TAVR procedure using the DurAVR™ THV System

Immediate post procedure

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness, including assessment of mortality and complications

30 days

1 visit (in-person)

Extended Follow-up

Participants are monitored for long-term safety and effectiveness, including assessment of leaflet thickening and hospitalizations

1 year

2 visits (in-person)

Long-term Follow-up

Participants are consented for follow-up to 10 years to assess long-term outcomes

10 years

What Are the Treatments Tested in This Trial?

Interventions

• DurAVR™ THV System

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

The Edwards SAPIEN transcatheter heart valve (THV) is considered noninferior to traditional surgical aortic valve replacement for high-risk operable patients, based on the high-risk arm of the PARTNER trial.

Despite some concerns about safety and trial misconduct, the FDA panel unanimously agreed that the benefits of the Edwards SAPIEN THV outweigh the risks, leading to its approval for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients. Barbash, IM., Dvir, D., Waksman, R.[2013]

The SAPIEN XT transcatheter heart valve system is associated with significantly fewer overall and major vascular complications compared to the original SAPIEN system, making it a safer option for patients with severe aortic stenosis who cannot undergo surgery.

Both SAPIEN and SAPIEN XT systems showed similar effectiveness in reducing all-cause mortality, major stroke, and rehospitalization rates at one year, indicating that the newer SAPIEN XT system maintains therapeutic efficacy while improving safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery. Webb, JG., Doshi, D., Mack, MJ., et al.[2022]

In a study of 169 patients undergoing transcatheter aortic valve replacement (TAVR) with Portico heart valves and FlexNav delivery systems, procedural success was achieved in 95.9% of cases with no procedural mortality, indicating high safety and efficacy of the intervention.

At one year post-procedure, the rates of all-cause mortality and neurological events were low at 10.7% and 7.7%, respectively, demonstrating favorable long-term outcomes and satisfactory hemodynamic results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Life Performance and Clinical Outcomes of Portico Transcatheter Aortic Valve with FlexNav Delivery System: One-Year Data from a Single-Center Experience. Yildirim, A., Genc, O., Pacaci, E., et al.[2023]

Citations

1. anteristech.com anteristech.com/clinical-evidence.html

DurAVR® THV Clinical Evidence When compared to a healthy aortic valve using cardiac MRI, DurAVR® THV showed no significant difference in flow. In addition, baseline 4D cardiac MRI from ...

2. biospace.com biospace.com/press-releases/anteris-technologies-announces-one-year-clinical-outcomes-for-duravr-thv-to-be-presented-at-tct-2025

Anteris Technologies Announces One-Year Clinical ... The presentation focuses on one-year clinical outcomes for the DurAVR® THV in symptomatic severe aortic stenosis patients with small aortic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05712161

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

4. finance.yahoo.com finance.yahoo.com/news/anteris-duravr-thv-demonstrates-favorable-220800782.html

Anteris DurAVR® THV Demonstrates Favorable ... At one-year, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalvular leak (PVL). At 30- ...

5. eurointervention.pcronline.com eurointervention.pcronline.com/article/early-safety-and-feasibility-of-a-first-in-class-biomimetic-transcatheter-aortic-valve-duravr

Early safety and feasibility of a first-in-class biomimetic ... DurAVR THV recipients had comparable flow displacement (14±10 cm vs 10±5 cm; p=0.453) and minimal flow reversal ratio (4±6% vs 1±1%; p=0.328) to the controls.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05182307

DurAVR™ THV System: First-In-Human Study A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the ...