Aortic StenosisDurAVR™ EFSNCT05712161
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
A study testing DurAVRTM THV System in people with Aortic Stenosis and Symptomatic Aortic Stenosis, run by Anteris Technologies Ltd. at 5 sites in United States.
Trial summary
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Stenosis, Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
- What is being tested?
- DurAVRTM THV System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Aug 2023to Dec 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects are eligible for entry in this study if ALL the following conditions are met:
- 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)
- Eligible for transfemoral delivery of the DurAVR™ THV
- Anatomy appropriate to accommodate safe placement of DurAVR™ THV (Preprocedural measurements by TTE and CT required: aortic annulus diameter 21-23 mm by CT)
- Understands the study requirements and the treatment procedures and provides written informed consent
- Subject agrees to complete all required scheduled follow-up visits.
Who cannot join
- Subjects are eligible for entry in this study if NONE of the following conditions are met:
- Anatomical
- Anatomy precluding safe placement of DurAVR™ THV
- Pre-existing prosthetic heart valve in any position
- Unicuspid or bicuspid aortic valve
- Severe aortic regurgitation
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- Severe mitral or severe tricuspid regurgitation requiring intervention.
- Moderate to severe mitral stenosis.
- Hypertrophic obstructive cardiomyopathy
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.
- Severe basal septal hypertrophy with outflow gradient
- Clinical
- Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
- Determined inoperable/ineligible for surgery by the Heart Team
- Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
- Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
- Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
- Need for emergency surgery for any reason
- Ventricular dysfunction with left ventricular ejection fraction (LVEF) < 30% as measured by resting echocardiogram
- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- Symptomatic carotid or vertebral artery disease
- End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
- GI bleeding within the past 3 months
- 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
- Ongoing sepsis, including active endocarditis (Duke Criteria) [49]
- Subject refuses a blood transfusion
- Life expectancy < 12 months due to associated non-cardiac co-morbid conditions
- Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent
- Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
- Currently participating in an investigational drug or another investigational device trial
- Subject is contraindicated for MDCT or MRI Scans.
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Columbia University Medical Center/NYPH
New York, New York, 10032
Montefiore Medical Center
The Bronx, New York, 10467
Tucson Medical Center
Tucson, Arizona, 85712
About this study
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
Read the detailed description
The primary objective is to assess the acute and long-term safety and feasibility of the DurAVR™ device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement as assessed by the Heart Team at the enrolling institutions.
This is a prospective, non-randomized, single-arm, multi-center Study. Subjects will be consented for follow-up to 10 years.
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Being tested
- DurAVRTM THV System
- Keywords
- TAVI, TAVR, Transcatheter Valve, Transcatheter Aortic Valve Implantation
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurAVRTM THV SystemDevice
The DurAVR™ Transcatheter Heart Valve (THV) is a balloon expandable transcatheter aortic valve
| Study group | Role | What they receive |
|---|---|---|
| DurAVR™ THV System | Experimental | TAVR procedure Receives: Device: DurAVRTM THV System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality or disabling stroke
Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines
Measured: 30days
Technical success
Freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device.
Measured: Immediate post procedure
Secondary outcomes (8)
All-cause mortality
Mortality would be reported as rate of death/mortality at 30days.
Measured: 30days
Disabling stroke
Rate of disabling stroke according to VARC-3 Guidelines
Measured: 30days
Major vascular, access-related, or cardiac structural complication
complications according to VARC-3 Guidelines
Measured: 30days
VARC-3 Type 2-4 bleeding
Rates of Type 2, 3, and 4 bleeding according to VARC-3 guidelines
Measured: 30days
Acute Kidney Injury stage 3 or 4
AKI stage 3-4 according to VARC-3 guidelines
Measured: 30days
Moderate or severe aortic regurgitation
aortic regurgitation according to VARC-3 guidelines
Measured: 30days
New permanent pacemaker due to procedure related conduction abnormalities
Rate of pacemaker interventions in subjects experiencing conduction abnormalities
Measured: 30days
Surgery or intervention related to the device, including aortic valve reintervention.
Device related interventions
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start7 Aug 2023
- Primary completion29 Dec 2023
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, non-randomized, single-arm, multi-center study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anteris Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Reardon, MD, Study chair, Methodist DeBakey Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712161
- Sponsor's protocol ID
- SP0028
- Acronym
- DurAVR™ EFS
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No