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LANDMARK Trial: a Randomised Controlled Trial of Myval THV — LANDMARK  

Aortic Valve Stenosis Clinical Trial

Official title:
A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis

Clinical Trial 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)

Clinical Trial Description

LANDMARK Trial is a prospective, randomised, multinational, multicentric, open-label non-inferiority trial of total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) with severe symptomatic native aortic valve stenosis via transfemoral approach. - Device sizes applicable for the Myval THV Series: 20 mm, 21.5 mm, 23 mm, 24.5 mm, 26 mm, 27.5 mm, and 29 mm diameter. - Device sizes applicable for the Sapien 3 THV Series: 20 mm, 23 mm, 26 mm, and 29 mm diameter. - Device sizes applicable for the Evolut THV Series: 23 mm, 26 mm, 29 mm, and 34 mm diameter. A non-randomised nested registry will be conducted to include patients requiring extra-large size of Myval THV series (XL Nested Registry) - Device sizes applicable for the XL Nested Registry: 30.5 mm and 32 mm. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04275726
Study type Interventional
Source Meril Life Sciences Pvt. Ltd.
Contact Ashok Thakkar, PhD
Phone +91-9879443584
Email ashok.thakkar@merillife.com
Status Recruiting
Phase N/A
Start date November 4, 2020
Completion date December 31, 2033
View Details
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