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.
ID: NCT04275726
Sponsor
Study objectives
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.
Primary endpoints
Primary Combined safety and effectiveness Endpoint(s): [Time frame: 30 days]
Conduction system disturbances resulting in a new permanent pacemaker implantation.
Secondary Endpoints 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
CERC Services
- CoreLab activities
Countries
17 countries: Belarus, Brazil, Croatia, Estonia, France, Germany, Greece, Hungary, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden
Number of investigational sites
67
Number of patients
988
