LANDMARK Trial and Version 1.0.1 dated 01-Jun-2020
Research type
Research Study
Full title
A prospective, multinational, multicentre, open-label, randomized, non-inferiority trial to compare safety and effectiveness of Meril’s Myval Transcatheter Heart Valve (THV) series vs. Contemporary Valves (Edwards’ Sapien THV series and Medtronic’s Evolut THV series) in patients with severe symptomatic native aortic valve stenosis.
IRAS ID
278045
Contact name
Andreas Baumbach
Contact email
Sponsor organisation
Meril Life Sciences Pvt Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 3 months, 31 days
Research summary
LANDMARK is a global trial designed to compare the safety and effectiveness of Meril’s Myval Transcatheter Heart Valve (THV) series vs. Contemporary Valves (Edwards’ Sapien THV series and Medtronic’s Evolut THV series) in patients who require replacement of their diseased aortic heart valve. A total of 768 patients are planned to be included globally with 3-6 centres participating from UK.
All patients will undergo informed consent process and screening procedures to determine their eligibility for participating in the trial. This includes procedures such as blood test, ECHO (a diagnostic test to take images of the heart using ultrasound waves), ECG (to measure heart rhythm) and CT angiography (to find any narrowed or closed blood vessels) prior to valve implant procedure (Index procedure). Once eligibility is confirmed, patients will be assigned to respective study groups by the process of randomization. ‘Randomization’ is process of allocating the patients to particular study group by a system generated process. LANDMARK involves 1:1 randomization which means there is 50% chance of receiving either Myval or contemporary valve.Post surgery, patients will have to visit the hospital at 30 days, 1-year, 3-year, 5-year, 7-year and 10-year for clinical, ECG and ECHO evaluations. Telephonic follow up will be conducted at 6-month, 2-year and 4-year.
The study has ‘Lead-In set’ which means, at every participating centre, minimum of 2 Lead-In patients will be enrolled for principle Investigator/ site staff to get familiar with study & procedure details. These Lead-In patients will not be randomized in the study. Hence, they will only receive Myval THV series. The ‘Lead-In’ cases will be supervised by ‘Lead-In-Evaluation Committee’ who shall ‘approve’ a participating Investigator as an independent recruiter of study.
REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0034
Date of REC Opinion
25 Jan 2021
REC opinion
Favourable Opinion