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

NCT05712161 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-04-08

No results posted yet for this study

Summary

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

Conditions

  • Aortic Stenosis
  • Symptomatic Aortic Stenosis
  • Severe Aortic Valve Stenosis
  • Aortic Valve Calcification

Interventions

DEVICE

DurAVRTM THV System

The DurAVR™ Transcatheter Heart Valve (THV) is a balloon expandable transcatheter aortic valve

Sponsors & Collaborators

  • Anteris Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Michael Reardon, MD · Methodist DeBakey Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-07
Primary Completion
2023-12-29
Completion
2033-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05712161 on ClinicalTrials.gov