NCT06510855

DurAVR™ THV EU-EFS

DurAVR™ THV System: European Early Feasibility Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Anteris Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves.

Detailed description

The DurAVR™ THV System is a novel balloon-expandable single-piece transcatheter aortic valve. The study will enroll up to 40 subjects with severe, symptomatic native aortic stenosis or with severe degeneration of surgically implanted aortic bioprosthetic valves, with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis. Subjects will be consented for follow-up to 5 years.

Conditions

• Symptomatic Aortic Stenosis
• Severe Aortic Valve Stenosis
• Aortic Valve Calcification
• Aortic Valve Failure
• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	DurAVR™ THV System	DurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-06-01
• Completion: 2030-10-01
• First posted: 2024-07-19
• Last updated: 2024-07-23