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Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial

NCT02799823 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-05-31

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

HLT Transcatheter Aortic Valve System

Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System

Sponsors & Collaborators

  • HLT Inc.

    lead INDUSTRY

Principal Investigators

  • Mathew Williams, MD · NYU Langone Medical Center

  • Dean Kereiakes, MD · The Christ Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-27
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 NCT02799823 on ClinicalTrials.gov