NCT06510855Active, not recruiting
DurAVR™ THV EU-EFS
DurAVR™ THV System: European Early Feasibility Study
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 15 Jul 2024
- Start date
- 21 Jan 2025
- Primary completion date
- 11 Jun 2026
- Lead sponsor
- Anteris Technologies Ltd.
- NCT number
- NCT06510855
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 21 Jan 2025 to the primary completion date, 11 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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
Other illness
- GI bleeding within the past 3 months
- Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions
Lab values
- End-stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min
Other
- 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
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.