LANDMARK Trial: a Randomised Controlled Trial of Myval THV

Launched by MERIL LIFE SCIENCES PVT. LTD. · Feb 17, 2020

Keywords

ClinConnect Summary

The LANDMARK Trial is a research study designed to compare a new type of heart valve called Myval THV with two existing heart valves, Sapien and Evolut, in patients suffering from severe aortic valve stenosis. Aortic valve stenosis is a condition where the heart's aortic valve becomes narrowed, making it difficult for the heart to pump blood effectively. The study will include 768 participants, and they will be randomly assigned to receive either the Myval THV or one of the contemporary valves, ensuring that both groups have equal chances of receiving either option.

To participate in this trial, individuals must be at least 18 years old and have received approval from their healthcare team to undergo a procedure called Transcatheter Aortic Valve Implantation (TAVI). This procedure is a minimally invasive way to replace the aortic valve. Participants will need to provide written consent to join the study. If you or someone you know is dealing with this heart condition and is interested in being part of this research, it’s important to talk to a healthcare provider to see if they meet the eligibility criteria and learn more about what participating in the trial would involve.

Gender

ALL

Eligibility criteria

• 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.