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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1year
Awards & highlights
DurAVR™ EFS Trial 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.Check my eligibility
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).See study design
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.
DurAVR™ EFS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 65 and have severe symptoms from aortic valve narrowing.
Select...
I need a new heart valve and my doctors recommend a less invasive procedure.
DurAVR™ EFS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All-cause mortality or disabling stroke
Technical success
Secondary outcome measures
Acute Kidney Injury stage 3 or 4
All-cause mortality
Disabling stroke
+5 moreOther outcome measures
Hospitalization (or re-hospitalization)
Leaflet thickening and reduced motion
DurAVR™ EFS 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
4 Previous Clinical Trials
103 Total Patients Enrolled
Admedus Regen Pty Ltd.Lead Sponsor
6 Previous Clinical Trials
403 Total Patients Enrolled
Michael Reardon, MDStudy ChairMethodist DeBakey Hospital
5 Previous Clinical Trials
4,613 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an artificial heart valve.I do not have severe dementia that affects my daily independence or ability to follow treatment.I am not allergic to aspirin, heparin, nitinol, ticlopidine, clopidogrel, or contrast media.You have other health problems that may make your expected life span less than 12 months.I am over 65 and have severe symptoms from aortic valve narrowing.I have not had any GI bleeding in the last 3 months.I am on chronic dialysis or my kidneys filter less than 20 cc/min.My heart has a thickened wall causing blood flow issues.You cannot have a MDCT or MRI scan for medical reasons.I had a heart or blood vessel procedure within the last 30 days.I have a serious heart artery problem that hasn't been treated with surgery.Your heart anatomy can safely fit the DurAVR™ THV, as measured by TTE and CT scans showing aortic annulus diameter of 21-23 mm.I have severe heart failure requiring medication or mechanical support.I do not have severe blood disorders like very low white blood cells or platelets, bleeding problems, or clotting issues.You had a heart attack less than 30 days ago.I have a heart condition that needs treatment.I refuse to receive blood transfusions.I have a significant narrowing of my heart's mitral valve.I have a thickened heart muscle that obstructs blood flow.My aortic valve has one or two flaps.I have not had a stroke or mini-stroke in the last 6 months.I have symptoms from narrowed neck arteries.I do not have an ongoing infection in my bloodstream.Able to have the DurAVR™ THV inserted through the leg artery.I need treatment for a severe heart valve issue.I have severe leakage in my aortic valve.My Heart Team has decided I cannot have heart surgery.My heart's structure allows for safe placement of a specific valve.My heart's pumping ability is significantly reduced.I need emergency surgery.I need a new heart valve and my doctors recommend a less invasive procedure.
Research Study Groups:
This trial has the following groups:- Group 1: DurAVR™ THV System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the geographical scope of this trial's implementation?
"This clinical trial is being offered in multiple medical centres, such as Montefiore Medical Center of Bronx, Columbia University Medical Cente/NYPH of New york and Cleveland Clinic Foundation from Cleveland. Additionally, there are 4 other sites that have been included in the study."
Answered by AI
Are there any open enrollment opportunities for this experiment?
"According to the clinicaltrials.gov website, this medical trial is no longer actively enrolling patients as it was most recently updated on May 11th 2023. However, there are still 311 other experiments that are open for recruitment at present."
Answered by AI
What is the fundamental aim of this trial?
"As per Anteris Technologies Ltd., the primary outcome to be monitored across a month-long period is Technical success. Along with this, there are three secondary outcomes that will also be measured: Disabling stroke (according to VARC-3 Guidelines), All-cause mortality (rate of death/mortality at 30 days) and Major vascular, access-related or cardiac structural complications (as delineated by VARC-3)."
Answered by AI
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