RecruitingNot Applicable

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

Belarus, Brazil, Croatia988 participantsStarted 2020-11-04

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient ≥18 years of age.
✓. 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.
✓. 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

✕. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.
✕. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.

What they're measuring

Primary Combined Safety and Effectiveness Endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3)

Timeframe: 30-day

Trial details

NCT IDNCT04275726

SponsorMeril Life Sciences Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-07

Contact for this trial

Ashok Thakkar, PhD

+91-9879443584 ashok.thakkar@merillife.com

View on ClinicalTrials.gov More Aortic Valve Stenosis trials