Last updated 9 months ago
LANDMARK Trial: a Randomised Controlled Trial of Myval THV
768 patients around the world
Available in Spain, Brazil
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.
Meril Life Sciences Pvt. Ltd.
1Research sites
768Patients around the world
This study is for people with
Coronary heart disease
Coronary stenosis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Patient ≥18 years of age.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.As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.
- Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.
Sites
Instituto Dante Pazzanese de Cardiology
Recruiting
StudyLANDMARK
SponsorMeril Life Sciences Pvt. Ltd.
Conditions
Coronary stenosis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04275726
