NCT07194265 · Anteris Technologies Ltd.
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
(PARADIGM)
What this study is about
forward-looking, randomly assigned, controlled, conducted at multiple hospitals, 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 randomly assigned group of participants'.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- San Francisco, California
- Clearwater, Florida
- Wichita, Kansas
- Baltimore, Maryland
- Boston, Massachusetts
- Minneapolis, Minnesota
- St Louis, Missouri
- The Bronx, New York
- Cincinnati, Ohio
- Germantown, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations