Comparing the DurAVR transcatheter heart valve with SAPIEN and Evolut valves for severe aortic stenosis

A Prospective Randomized Trial Assessing the Safety and Effectiveness of the DurAVR® Biomimetic Valve Designed for Physiologic Flow Compared to Commercial TAVR Devices

This trial will test whether the DurAVR transcatheter heart valve works as well and is as safe as SAPIEN or Evolut valves in people with severe calcific aortic stenosis, and it also includes a registry for people needing valve‑in‑valve procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1650 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Anteris Technologies Ltd. (Industry-sponsored)
• Locations: 3 sites (The Bronx, New York and 2 other locations)
• Trial ID: NCT07194265 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, controlled, multicenter international trial enrolling up to 1,054 patients with severe native calcific aortic stenosis who are candidates for TAVR and randomizing them 1:1 to the DurAVR THV or a commercially available SAPIEN or Evolut THV, with planned follow‑up for 10 years. After the main randomized cohort, up to 446 additional low‑risk subjects will be randomized in a continued access cohort. Separately, up to 150 high surgical risk patients needing valve‑in‑valve TAVR for a failed surgical bioprosthesis will be enrolled in a DurAVR registry and followed for 5 years. Outcomes will compare safety and effectiveness between devices across participating international centers.

Who should consider this trial

Good fit: Adults with severe native calcific aortic stenosis judged by the local Heart Team to need TAVR are eligible for randomization, and high surgical risk patients with a failed surgical bioprosthesis are eligible for the valve‑in‑valve registry.

Not a fit: Patients whose aortic annulus or vascular anatomy is incompatible with the available DurAVR or control valve sizes, or who are not candidates for TAVR, are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, DurAVR could provide patients an additional transcatheter valve option with comparable safety and effectiveness to currently used commercial valves and expand options for valve‑in‑valve procedures.

How similar studies have performed: Commercial SAPIEN and Evolut THV systems have extensive evidence of safety and effectiveness, while DurAVR is a newer device with limited published long‑term comparative data, making this randomized comparison relatively novel.

Eligibility criteria

Inclusion Criteria:

Native Aortic Stenosis Cohorts:

1. The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
2. 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.
3. Subject understands the study requirements and the treatment procedure and provides written informed consent.

ViV Registry Cohort:

1. Severe degeneration of a surgically implanted aortic bioprosthetic valve.
2. 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.
3. Subject understands the study requirements and the treatment procedure and provides written informed consent.

Exclusion Criteria:

Native Aortic Stenosis Cohorts:

1. Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis.
2. Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control).
3. Evidence of an acute myocardial infarction 30 days before randomization.
4. AV is unicuspid, Type 0 bicuspid, or is non-calcified.
5. Severe total aortic regurgitation
6. Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis.
7. Pre-existing mechanical or bioprosthetic valve in any position.
8. Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
9. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
10. Active bacterial endocarditis in the last 3 months.
11. Estimated life expectancy (after TAVR) \<12 months.
12. Subject is not a candidate for both arms (investigational and control) of the study.
13. Subject belongs to a vulnerable population

ViV Registry Cohort:

1. Anatomy precluding safe placement of DurAVR THV.
2. Pre-existing prosthetic heart valve in the mitral, tricuspid or pulmonary position.
3. Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis
4. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation.
5. Failing surgical aortic bioprosthesis is unstable, rocking, or not structurally intact.
6. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
7. Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
8. Need for emergency surgery for any reason
9. GI bleeding within the past 3 months.
10. Active bacterial endocarditis in the last 3 months.
11. Estimated life expectancy (after TAVR) \<12 months.
12. Subject belongs to a vulnerable population.

Where this trial is running

The Bronx, New York and 2 other locations

• Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
• The Stern Cardiovascular Foundation — Germantown, Tennessee, United States (Recruiting)
• Rigshospitalet — Copenhagen, Capital Region of Denmark, Denmark (Recruiting)

Study contacts

• Study coordinator: Jennifer Englund

Conditions Severe Aortic Stenosis; Valve-in-valve Procedures; tavr; severe calcific aortic stenosis; failed surgical bioprosthesis