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HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation

NCT05409378 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-05-31

No results posted yet for this study

Summary

To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.

Conditions

  • Aortic Regurgitation

Interventions

DEVICE

The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)

Aortic valve replacement with the HLT Meridian TAVR Valve to treat aortic regurgitation

Sponsors & Collaborators

  • HLT Inc.

    lead INDUSTRY

Principal Investigators

  • Kendra Grubb, MD · Emory University

  • Charles Davidson, MD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-08
Primary Completion
2023-01-20
Completion
2023-01-20
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 NCT05409378 on ClinicalTrials.gov