NCT07194265

A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,650 (estimated)
• Sponsor: Anteris Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Severe Aortic Stenosis
• Valve-in-valve Procedures

Interventions

Type	Name	Description
DEVICE	TAVR with DurAVR® THV	Transcatheter aortic valve replacement (TAVR)
DEVICE	TAVR with SAPIEN THV series or the Evolut THV series	Transcatheter aortic valve replacement (TAVR)

Timeline

• Start date: 2025-10-21
• Primary completion: 2027-12-01
• Completion: 2038-03-01
• First posted: 2025-09-26
• Last updated: 2026-04-08

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study