Symptomatic Aortic StenosisNCT06510855
DurAVR™ THV EU-EFS
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 Denmark.
Trial summary
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Jan 2025to Aug 2031
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older.
- Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team
- Eligible for transfemoral 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
- Anatomy precluding safe placement of DurAVR™ THV
- Pre-existing prosthetic mitral or tricuspid valve
- Unicuspid, bicuspid or non-calcified aortic valve
- Severe mitral or severe tricuspid regurgitation requiring intervention
- Moderate to severe mitral stenosis
- Hypertrophic obstructive cardiomyopathy
Show all 14Show fewer
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
- Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
- Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- End-stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min
- GI bleeding within the past 3 months
- Ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months
- Life expectancy < 12 months due to associated non-cardiac co-morbid conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DurAVR™ THV System: European Early Feasibility Study
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves.
Read the detailed description
The DurAVR™ THV System is a novel balloon-expandable single-piece transcatheter aortic valve.
The study will enroll up to 15 subjects with severe, symptomatic native aortic stenosis or with severe degeneration of surgically implanted aortic bioprosthetic valves, with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.
Subjects will be consented for follow-up to 5 years.
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Failure, Aortic Valve Disease
- Being tested
- DurAVR™ THV System
- Keywords
- Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Valve, Valve-in-Valve, Aortic Valve Disease
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve, Calcification of, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurAVR™ THV SystemDevice
DurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure
| Study group | Role | What they receive |
|---|---|---|
| Severe Aortic Stenosis (sAS) Cohort | Experimental | Subjects with symptomatic severe native aortic stenosis with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis. Receives: Device: DurAVR™ THV System |
| Failed Surgical Aortic Bioprosthetic Valve (FAV) Cohort | Experimental | Subjects with severe degeneration of surgically implanted aortic bioprosthetic valves with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis. Receives: Device: DurAVR™ 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: 30 Days
Secondary outcomes (8)
All-cause mortality
Mortality would be reported as rate of death/mortality at 30 days.
Measured: 30 Days
Disabling stroke
Disabling stroke would be reported according to VARC-3 Guidelines
Measured: 30 Days
Life-threatening bleeding
Life-threatening bleeding according to VARC-3 Guidelines
Measured: 30 Days
Major vascular, access-related, or cardiac structural complication
Major vascular, access-related, or cardiac structural complication according to VARC-3 Guidelines
Measured: 30 Days
Acute kidney injury stage 3 or 4
AKI according to VARC-3 Guidelines
Measured: 30 Days
Moderate or severe aortic regurgitation
Aortic regurgitation according to VARC-3 Guidelines
Measured: 30 Days
New permanent pacemaker due to procedure related conduction abnormalities
Rate of pacemaker interventions in subjects experiencing conduction abnormalities (sAS cohort only)
Measured: 30 Days
Surgery or intervention related to the device, including aortic valve reintervention
Device related interventions
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start21 Jan 2025
- Primary completion11 Jun 2026
- Study completionAug 2031 (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
- Non-randomised
- Intervention model
- Parallel groups
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510855
- Sponsor's protocol ID
- SP0082
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DurAVR™ THV System: European Early Feasibility Study
- ClinicalTrials.gov ID
- NCT06510855
- Acronym / sponsor ID
- SP0082
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Failure, Aortic Valve Disease
- Keywords
- Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Valve, Valve-in-Valve, Aortic Valve Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Anteris Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- Aug 2031 (estimated)
- First posted
- 19 Jul 2024 (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, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves.
Detailed description
The DurAVR™ THV System is a novel balloon-expandable single-piece transcatheter aortic valve.
The study will enroll up to 15 subjects with severe, symptomatic native aortic stenosis or with severe degeneration of surgically implanted aortic bioprosthetic valves, with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.
Subjects will be consented for follow-up to 5 years.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe Aortic Stenosis (sAS) Cohort | Experimental | Device: DurAVR™ THV SystemSubjects with symptomatic severe native aortic stenosis with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis. |
| Failed Surgical Aortic Bioprosthetic Valve (FAV) Cohort | Experimental | Device: DurAVR™ THV SystemSubjects with severe degeneration of surgically implanted aortic bioprosthetic valves with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older.
- Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team
- Eligible for transfemoral 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
Key exclusion criteria (14 listed)
- Anatomy precluding safe placement of DurAVR™ THV
- Pre-existing prosthetic mitral or tricuspid valve
- Unicuspid, bicuspid or non-calcified aortic valve
- Severe mitral or severe tricuspid regurgitation requiring intervention
- Moderate to severe mitral stenosis
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 SystemDurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure | Device | Failed Surgical Aortic Bioprosthetic Valve (FAV) Cohort, Severe Aortic Stenosis (sAS) Cohort |
Primary outcome
All-cause mortality or disabling stroke
Time frame: 30 Days
Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines
8 secondary outcomes
All-cause mortality
Time frame: 30 Days
Disabling stroke
Time frame: 30 Days
Life-threatening bleeding
Time frame: 30 Days
Major vascular, access-related, or cardiac structural complication
Time frame: 30 Days
Acute kidney injury stage 3 or 4
Time frame: 30 Days
Moderate or severe aortic regurgitation
Time frame: 30 Days
New permanent pacemaker due to procedure related conduction abnormalities
Time frame: 30 Days
Surgery or intervention related to the device, including aortic valve reintervention
Time frame: 30 Days
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 16 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Denmark.
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 6 inclusion and 14 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 16 Sep 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 Denmark. 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?
All-cause mortality or disabling stroke (time frame: 30 Days). 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 16 Sep 2026.