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HLT Meridian Valve CE Mark Trial

NCT03805711 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-05-19

No results posted yet for this study

Summary

To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

HLT® Transcatheter System

Transcatheter aortic valve replacement using The HLT® Transcatheter System (HLT System) in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery (Heart Team agrees that the risk of 30-day mortality is ≥ 3%).

Sponsors & Collaborators

  • HLT Inc.

    lead INDUSTRY

Principal Investigators

  • Axel Linke, MD · Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-12
Primary Completion
2019-09-20
Completion
2019-09-20
FDA Device
Yes

Countries

  • Canada

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 NCT03805711 on ClinicalTrials.gov