Actively Recruiting
A Prospective Randomized Trial Assessing the Safety and Effectiveness of the DurAVR4 Biomimetic Valve Compared to Commercial TAVR Devices in Severe Aortic Stenosis
Led by Anteris Technologies Ltd. · Updated on 2026-06-03
1650
Participants Needed
4
Research Sites
534 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the DurAVR4 biomimetic valve compared to other commercially available transcatheter heart valves (THVs) in adults with severe native calcific aortic stenosis who require Transcatheter Aortic Valve Replacement (TAVR). This prospective, randomized, controlled, multicenter international study includes subjects determined by the local Heart Team to benefit from TAVR. The study also includes a separate group of patients with failed surgical bioprosthetic valves who need valve-in-valve TAVR and are considered high surgical risk. Participants will be randomized to receive either the DurAVR4 THV system or a control THV from the SAPIEN or Evolut series. Up to 1054 subjects will be enrolled in the main randomized cohort and followed for 10 years. Additionally, up to 446 low-risk subjects will be randomized in a continued access cohort. A separate nested registry will enroll up to 150 high-risk subjects needing valve-in-valve TAVR who will only receive the DurAVR4 THV. Treatments are delivered by transcatheter implantation, and the study compares these devices in real-world clinical settings. During the study, participants will undergo assessments including mortality, stroke, and cardiovascular hospitalizations over one year as primary outcomes. Secondary outcomes include mortality, disabling stroke, bleeding, vascular complications, and kidney injury within 30 days following the procedure. Participants will be monitored with imaging and clinical evaluations, and safety will be followed for up to 10 years in the main cohort and 5 years in the valve-in-valve registry. The study aims to provide long-term data on these heart valve devices and their impact on patient health.
CONDITIONS
Brief 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 or SAPIEN/Evolut THV systems
- Local Heart Team agrees there is an appropriate indication for TAVR due to severe native calcific aortic stenosis
- Able to understand study requirements and provides written informed consent
- For valve-in-valve registry: severe degeneration of a surgical aortic bioprosthetic valve
- High surgical risk and indicated for valve-in-valve TAVR as determined by Heart Team
- Able to understand study requirements and provides written informed consent
You will not qualify if you...
- Native aortic annulus size unsuitable for study valves based on CT imaging
- Access vessel anatomy that prevents safe introducer sheath placement
- Acute myocardial infarction within 30 days before randomization
- Unicuspid, Type 0 bicuspid, or non-calcified aortic valve
- Severe total aortic regurgitation
- Severe mitral or tricuspid regurgitation or moderate or worse mitral stenosis
- Pre-existing mechanical or bioprosthetic valve in any position (for native cohorts)
- Untreated clinically significant coronary artery disease needing revascularization
- Intracardiac mass, thrombus, or vegetation on imaging
- Active bacterial endocarditis in last 3 months
- Estimated life expectancy less than 12 months after TAVR
- Not a candidate for both study arms
- Vulnerable population
- For valve-in-valve registry: anatomy unsuitable for DurAVR placement
- Pre-existing prosthetic valve in mitral, tricuspid, or pulmonary position
- Failing surgical aortic bioprosthesis unstable or not intact
- Need for emergency surgery
- GI bleeding within past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo transcatheter aortic valve replacement (TAVR) using either the DurAVR® THV system or a commercial TAVR device.
1 visit (in-person)
Duration - 30 days
Participants are monitored after the valve replacement procedure for safety and effectiveness outcomes.
Approximately 3 visits (in-person)
Duration - 1 year
Participants are followed for up to 1 year to assess all-cause mortality, stroke, and cardiovascular hospitalization.
Scheduled visits throughout the year
Trial Site Locations
Total: 4 locations
1
Kaiser Permanente San Francisco
San Francisco, California, United States, 94118
Actively Recruiting
2
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
3
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States, 38138
Actively Recruiting
4
Rigshospitalet
Copenhagen, Capital Region of Denmark, Denmark, 2100
Actively Recruiting
Research Team
J
Jennifer Englund
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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