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LANDMARK Trial: a Randomised Controlled Trial of Myval THV

NCT04275726 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 988

Last updated 2025-04-04

No results posted yet for this study

Summary

The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.

This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)

The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Myval THV Series

The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.

DEVICE

Contemporary Valves (Sapien THV Series and Evolut THV Series)

The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.

Sponsors & Collaborators

  • Meril Life Sciences Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Andreas Baumbach, MD,FESC,FRCP · Barts Heart Center, London, UK

  • Patrick W. Serruys, MD,PhD,FACC,FESC · National University of Ireland, Galway, Ireland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2024-03-07
Completion
2033-12-31

Countries

  • Belarus
  • Brazil
  • Croatia
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden

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 NCT04275726 on ClinicalTrials.gov