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LANDMARK Trial: a Randomised Controlled Trial of Myval THV

RecruitingNAAges 18 Years - anyAllMeril Life Sciences Pvt. Ltd.
NCT04275726 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patient ≥18 years of age. 2. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) of the investigational site to participate in the study. 3. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices. Exclusion Criteria: 1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study. 2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.
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What it tests

  • Myval THV Series
  • Contemporary Valves (Sapien THV Series and Evolut THV Series)
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Where

54 sites
Republican Scientific-Practical Centre "Cardiology"
Minsk, Belarus
Hospital Dante Pazanesse
São Paulo, Brazil
Split Clinical Hospital Center
Split, Croatia
University Hospital Dubrava Avenija Gojka Šuška 6
Zagreb, Croatia
North Estonia Medical Center
Tallinn, Estonia
Hôpital Henri Mondor
Créteil, France
Lille University
Lille, France
Institut Cardiovascular Paris-Sud
Massy, France

…and 46 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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