Sponsor Name : Meril Life Sciences Pvt.Ltd.
Landmark Trial is a prospective, randomized, multinational, multicentric, open-label non-inferiority trial of approximately 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) with severe symptomatic native aortic valve stenosis via transfemoral approach.
Primary Combined safety and effectiveness Endpoint(s): [Time frame: 30 days]
Conduction system disturbances resulting in a new permanent pacemaker implantation.
Secondary Endpoint(s) related to the corelab analyses
1) The combined safety and effectiveness endpoint: [Time frame: 1-year]
2) New permanent pacemaker implantation [Time Frame: baseline, Pre-discharge, 30-days,1-year and 5-years] – New permanent pacemaker implantation rates will be analyzed further based on the patient’s history of left and/or right bundle branch block.
3) Conduction disturbances and arrhythmias according to VARC-2 [Time Frame: baseline, Pre-discharge, 30-days,1-year and 5-years]
4) New onset of atrial fibrillation or atrial flutter [Time Frame: Pre-discharge, 30-days, 1-year and 5-years]
5) Major Q-QS abnormalities according to Minnesota Code manual of ECG findings at baseline, pre-discharge, 6 months and 1year follow-up
67 European sites