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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rigshospitalet
  Copenhagen, Capital Region of Denmark, Denmark Recruiting

Study contacts

• Study coordinator: Emily Neumann
• Email: ENeumann@anteristech.com
• Phone: +1 414 550 7619

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.