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DurAVR™ THV System: First-In-Human Study

NCT05182307 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-01-31

No results posted yet for this study

Summary

A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.

Conditions

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

Interventions

DEVICE

DurAVR™ THV System

Transcatheter Aortic Valve Implantation (TAVI) Procedure

Sponsors & Collaborators

  • Anteris Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Chris Meduri, MD · Anteris Technologies

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Georgia

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 NCT05182307 on ClinicalTrials.gov