Actively Recruiting
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Led by Anteris Technologies Ltd. · Updated on 2026-05-11
1650
Participants Needed
3
Research Sites
644 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved Transcatheter Heart Valve (THV) from the SAPIEN series or the Evolut series and followed for 10 years. After completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'. Up to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.
CONDITIONS
Official Title
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidate for TAVR using DurAVR4 THV System or SAPIEN or Evolut THV systems
- Appropriate indication for TAVR due to severe native calcific aortic stenosis as determined by the local Heart Team
- Provides written informed consent and understands study requirements
- For ViV Registry Cohort: severe degeneration of a surgically implanted aortic bioprosthetic valve
- For ViV Registry Cohort: high surgical risk and indicated for Valve-in-Valve TAVR as determined by the Heart Team
- Provides written informed consent and understands study requirements (ViV Registry Cohort)
You will not qualify if you...
- Native aortic annulus size unsuitable for study THVs based on CT imaging
- Access vessel characteristics unsafe for introducer sheath placement
- Acute myocardial infarction within 30 days before randomization
- Aortic valve is unicuspid, Type 0 bicuspid, or non-calcified
- Severe total aortic regurgitation
- Severe mitral or tricuspid regurgitation or moderate or greater mitral stenosis
- Pre-existing mechanical or bioprosthetic valve in any position (for native cohorts)
- Untreated significant coronary artery disease requiring revascularization
- Intracardiac mass, thrombus, or vegetation seen on cardiac imaging
- Active bacterial endocarditis within the last 3 months
- Estimated life expectancy less than 12 months after TAVR
- Not a candidate for both investigational and control arms
- Belongs to a vulnerable population
- For ViV Registry Cohort: anatomy unsuitable for safe DurAVR THV placement
- Pre-existing prosthetic valve in mitral, tricuspid, or pulmonary position (ViV)
- Unstable, rocking, or structurally compromised failing surgical aortic bioprosthesis
- Need for emergency surgery
- Gastrointestinal bleeding within past 3 months (ViV)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
2
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States, 38138
Actively Recruiting
3
Rigshospitalet
Copenhagen, Capital Region of Denmark, Denmark, 2100
Actively Recruiting
Research Team
J
Jennifer Englund
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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