Symptomatic Aortic StenosisNCT05182307
DurAVR™ THV System: EMBARK Study
A study testing DurAVR™ THV System in people with Symptomatic Aortic Stenosis and Severe Aortic Valve Stenosis, run by Anteris Technologies Ltd. at 1 site in Georgia.
Trial summary
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 treatment of subjects with symptomatic severe aortic stenosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- What is being tested?
- DurAVR™ THV System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGeorgia
- Study dates
- 15 Nov 2021to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptomatic, severe aortic stenosis
- Eligible for delivery of the DurAVR™ THV
- Anatomy appropriate to accommodate safe placement of DurAVR™ THV
- 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
- Anatomical
- Anatomy precluding safe placement of DurAVR™ THV
- Pre-existing prosthetic heart valve in any position
- Unicuspid or bicuspid aortic valve
- Severe aortic regurgitation
- Severe mitral or severe tricuspid regurgitation requiring intervention
Show all 30Show fewer
- 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 < 1000mm3), 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
- 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 belongs to a vulnerable population.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: First In Human Study (EMBARK 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 treatment of subjects with symptomatic severe aortic stenosis.
Read the detailed description
The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve.
The study will enroll up to 150 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year.
- Being tested
- DurAVR™ THV System
- Keywords
- TAVI, TAVR, Transcatheter Aortic Valve Implantation, Transcatheter valve
- 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.
DurAVR™ THV SystemDevice
Transcatheter Aortic Valve Implantation (TAVI) Procedure
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | DurAVR™ THV System Receives: Device: DurAVR™ THV System |
What is being measured
The primary outcome is the main question the study is designed to answer.
DurAVR™ prosthetic heart valve implant
Number of subjects for which a single DurAVR™ prosthetic heart valve was correctly positioned into the proper anatomical location
Measured: Immediate post procedure
Hemodynamic performance
Effective Orifice Area (EOA), Mean gradient, Aortic Regurgitation, Paravalvular Leak (PVL), Doppler Velocity Index (DVI)
Measured: Immediate post procedure
All-cause mortality
All-cause mortality
Measured: 30 days
All-cause mortality
All-cause mortality
Measured: 1 year
Myocardial infarction
Myocardial infarction
Measured: 30 days
Myocardial infarction
Myocardial infarction
Measured: 1 year
Stroke
Disabling Stroke (VARC-3 Guidelines)
Measured: 30 days
Stroke
Disabling Stroke (VARC-3 Guidelines)
Measured: 1 year
Life-threatening bleeding
Life-threatening bleeding (VARC-3 Guidelines)
Measured: 30 days
Life-threatening bleeding
Life-threatening bleeding (VARC-3 Guidelines)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start15 Nov 2021
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anteris Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Meduri, MD, Study director, Anteris Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182307
- Sponsor's protocol ID
- SP0011
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2021
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: First In Human Study (EMBARK Study)
- ClinicalTrials.gov ID
- NCT05182307
- Acronym / sponsor ID
- SP0011
- Keywords
- TAVI, TAVR, Transcatheter Aortic Valve Implantation, Transcatheter valve
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Anteris Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 treatment of subjects with symptomatic severe aortic stenosis.
Detailed description
The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve.
The study will enroll up to 150 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: DurAVR™ THV SystemDurAVR™ THV System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic, severe aortic stenosis
- Eligible for delivery of the DurAVR™ THV
- Anatomy appropriate to accommodate safe placement of DurAVR™ THV
- Understands the study requirements and the treatment procedures and provides written informed consent.
- Subject agrees to complete all required scheduled follow-up visits.
Key exclusion criteria (30 listed)
- Anatomical
- Anatomy precluding safe placement of DurAVR™ THV
- Pre-existing prosthetic heart valve in any position
- Unicuspid or bicuspid aortic valve
- Severe aortic regurgitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurAVR™ THV SystemTranscatheter Aortic Valve Implantation (TAVI) Procedure | Device | Treatment |
Primary outcome
DurAVR™ prosthetic heart valve implant
Time frame: Immediate post procedure
Number of subjects for which a single DurAVR™ prosthetic heart valve was correctly positioned into the proper anatomical location
Hemodynamic performance
Time frame: Immediate post procedure
Effective Orifice Area (EOA), Mean gradient, Aortic Regurgitation, Paravalvular Leak (PVL), Doppler Velocity Index (DVI)
All-cause mortality
Time frame: 30 days
All-cause mortality
All-cause mortality
Time frame: 1 year
All-cause mortality
Myocardial infarction
Time frame: 30 days
Myocardial infarction
Myocardial infarction
Time frame: 1 year
Myocardial infarction
Stroke
Time frame: 30 days
Disabling Stroke (VARC-3 Guidelines)
Stroke
Time frame: 1 year
Disabling Stroke (VARC-3 Guidelines)
Life-threatening bleeding
Time frame: 30 days
Life-threatening bleeding (VARC-3 Guidelines)
Life-threatening bleeding
Time frame: 1 year
Life-threatening bleeding (VARC-3 Guidelines)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Meduri, MD study director
Anteris Technologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DurAVR™ THV System in people with Symptomatic Aortic Stenosis and Severe Aortic Valve Stenosis, run by Anteris Technologies Ltd. at 1 site in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DurAVR™ prosthetic heart valve implant (time frame: Immediate post procedure). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.