DurAVR™ THV System for Aortic Stenosis

(DurAVR™ EFS Trial)

Recruiting at 6 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

15 Participants Needed

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.

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 data supports the effectiveness of the DurAVR™ THV System treatment for aortic stenosis?

The effectiveness of the DurAVR™ THV System for aortic stenosis can be indirectly supported by studies on similar transcatheter heart valve (THV) systems, which have shown to be effective in treating severe aortic stenosis, especially in patients at high surgical risk. These studies highlight the benefits of transcatheter aortic valve replacement (TAVR) as a standard treatment option, with data suggesting good long-term outcomes and durability. ^{1 2 3 4 5}

Is the DurAVR™ THV System safe for humans?

There is no specific safety data available for the DurAVR™ THV System, but similar transcatheter heart valves have shown positive safety outcomes in studies, with low rates of mortality and complications. ^{6 7 8 9 10}

How is the DurAVR™ THV System treatment different from other treatments for aortic stenosis?

The DurAVR™ THV System is a newer-generation transcatheter heart valve (THV) system designed to improve upon earlier models by offering better positioning and outcomes, similar to other advanced THV systems like Myval™. It is part of the evolving landscape of transcatheter aortic valve replacement (TAVR) options, which are alternatives to traditional surgical aortic valve replacement (SAVR) for patients at varying surgical risks. ^{1 2 5 11 12}

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.

Timeline

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

Treatment Details

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).

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term Follow-up After Transcatheter Aortic Valve Replacement. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Network Meta-analysis of Surgical Aortic Valve Replacement and Different Transcatheter Heart Valve Systems for Symptomatic Severe Aortic Stenosis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Myocardial functional changes in transfemoral versus transapical aortic valve replacement. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Structural durability of early-generation Transcatheter aortic valve replacement valves compared with surgical aortic valve replacement valves in heart valve surgery: a systematic review and meta-analysis. [2020]

6. France pubmed.ncbi.nlm.nih.gov

A systematic review on the safety of second-generation transcatheter aortic valves. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Comparison of a novel self-expanding transcatheter heart valve with two established devices for treatment of degenerated surgical aortic bioprostheses. [2023]

8. United States 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. [2013]

9. United States 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. [2022]

10. Switzerland 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Balloon-expandable prostheses for transcatheter aortic valve replacement. [2014]

12. England pubmed.ncbi.nlm.nih.gov

Myval transcatheter heart valve system in the treatment of severe symptomatic aortic stenosis. [2021]