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Transcatheter Aortic Valve Replacement (TAVR)

DurAVR™ THV System for Aortic Stenosis (DurAVR™ EFS Trial)

N/A
Waitlist Available
Research Sponsored by Anteris Technologies Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic, severe native aortic stenosis in subjects 65 years or older
Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)
Must not have
A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, nitinol (titanium or nickel), ticlopidine and clopidogrel, contrast media
GI bleeding within the past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1year
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new valve system to treat severe aortic stenosis, to see if it's safe and effective.

Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
While specific side effects are not listed here, similar procedures may involve risks such as bleeding at the catheter insertion site, infection risk from invasive procedures; allergic reactions to materials used like nitinol (titanium or nickel), contrast media; potential damage to blood vessels; irregular heartbeats; stroke risk during procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 65 and have severe symptoms from aortic valve narrowing.
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I need a new heart valve and my doctors recommend a less invasive procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic to aspirin, heparin, nitinol, ticlopidine, clopidogrel, or contrast media.
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I have not had any GI bleeding in the last 3 months.
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I am on chronic dialysis or my kidneys filter less than 20 cc/min.
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My heart has a thickened wall causing blood flow issues.
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I do not have severe blood disorders like very low white blood cells or platelets, bleeding problems, or clotting issues.
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I have a serious heart artery problem that hasn't been treated with surgery.
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I have severe heart failure requiring medication or mechanical support.
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I have a heart condition that needs treatment.
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I refuse to receive blood transfusions.
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I have a significant narrowing of my heart's mitral valve.
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I have a thickened heart muscle that obstructs blood flow.
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My aortic valve has one or two flaps.
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I have not had a stroke or mini-stroke in the last 6 months.
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I have symptoms from narrowed neck arteries.
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I do not have an ongoing infection in my bloodstream.
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I need treatment for a severe heart valve issue.
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I have severe leakage in my aortic valve.
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My Heart Team has decided I cannot have heart surgery.
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My heart's structure allows for safe placement of a specific valve.
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My heart's pumping ability is significantly reduced.
Select...
I need emergency surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
All-cause mortality or disabling stroke
Technical success
Secondary study objectives
Acute Kidney Injury stage 3 or 4
All-cause mortality
Disabling stroke
+5 more
Other study objectives
Hospitalization (or re-hospitalization)
Leaflet thickening and reduced motion

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DurAVR™ THV SystemExperimental Treatment1 Intervention
TAVR procedure

Find a Location

Who is running the clinical trial?

Anteris Technologies Ltd.Lead Sponsor
5 Previous Clinical Trials
143 Total Patients Enrolled
Admedus Regen Pty Ltd.Lead Sponsor
6 Previous Clinical Trials
403 Total Patients Enrolled
Michael Reardon, MDStudy ChairMethodist DeBakey Hospital
7 Previous Clinical Trials
5,071 Total Patients Enrolled

Media Library

DurAVR™ THV System (Transcatheter Aortic Valve Replacement (TAVR)) Clinical Trial Eligibility Overview. Trial Name: NCT05712161 — N/A
Aortic Stenosis Research Study Groups: DurAVR™ THV System
Aortic Stenosis Clinical Trial 2023: DurAVR™ THV System Highlights & Side Effects. Trial Name: NCT05712161 — N/A
DurAVR™ THV System (Transcatheter Aortic Valve Replacement (TAVR)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05712161 — N/A
~6 spots leftby Dec 2025
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