Status:
NOT_YET_RECRUITING
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Lead Sponsor:
Anteris Technologies Ltd.
Conditions:
Severe Aortic Stenosis
Valve-in-valve Procedures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 indicati...
Eligibility Criteria
Inclusion
- Native Aortic Stenosis Cohorts:
- The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
- The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis.
- Subject understands the study requirements and the treatment procedure and provides written informed consent.
- ViV Registry Cohort:
- Severe degeneration of a surgically implanted aortic bioprosthetic valve.
- Subject requires aortic valve replacement and is high surgical risk and is indicated for TAVR Valve-in-Valve procedure as determined by the Heart Team.
- Subject understands the study requirements and the treatment procedure and provides written informed consent.
Exclusion
- Native Aortic Stenosis Cohorts:
- Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis.
- Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control).
- Evidence of an acute myocardial infarction 30 days before randomization.
- AV is unicuspid, Type 0 bicuspid, or is non-calcified.
- Severe total aortic regurgitation
- Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis.
- Pre-existing mechanical or bioprosthetic valve in any position.
- Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
- Active bacterial endocarditis in the last 3 months.
- Estimated life expectancy (after TAVR) \<12 months.
- Subject is not a candidate for both arms (investigational and control) of the study.
- Subject belongs to a vulnerable population
- ViV Registry Cohort:
- Anatomy precluding safe placement of DurAVR THV.
- Pre-existing prosthetic heart valve in the mitral, tricuspid or pulmonary position.
- Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation.
- Failing surgical aortic bioprosthesis is unstable, rocking, or not structurally intact.
- Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
- Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
- Need for emergency surgery for any reason
- GI bleeding within the past 3 months.
- Active bacterial endocarditis in the last 3 months.
- Estimated life expectancy (after TAVR) \<12 months.
- Subject belongs to a vulnerable population.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2037
Estimated Enrollment :
1650 Patients enrolled
Trial Details
Trial ID
NCT07194265
Start Date
October 1 2025
End Date
December 1 2037
Last Update
October 15 2025
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