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Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study — DurAVR™ EFS  

Aortic Stenosis Clinical Trial

Official title:
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study

Clinical Trial Summary

To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.

Clinical Trial Description

The primary objective is to assess the acute and long-term safety and feasibility of the DurAVR™ device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement as assessed by the Heart Team at the enrolling institutions. This is a prospective, non-randomized, single-arm, multi-center Study. Subjects will be consented for follow-up to 10 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05712161
Study type Interventional
Source Anteris Technologies Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date August 7, 2023
Completion date December 2033
View Details
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