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

NCT02838680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-05-31

No results posted yet for this study

Summary

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

  • Josep Rodés-Cabau, MD · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  • Harindra Wijeysundera, MD · Sunnybrook Health Sciences Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-04-09
Completion
2022-10-31
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 NCT02838680 on ClinicalTrials.gov