Status:
RECRUITING
LANDMARK Trial: a Randomised Controlled Trial of Myval THV
Lead Sponsor:
Meril Life Sciences Pvt. Ltd.
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 se...
Detailed 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 symptom...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2033
Estimated Enrollment :
988 Patients enrolled
Trial Details
Trial ID
NCT04275726
Start Date
November 4 2020
End Date
December 31 2033
Last Update
April 4 2025
Active Locations (54)
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1
Republican Scientific-Practical Centre "Cardiology"
Minsk, Belarus, 220036
2
Hospital Dante Pazanesse
São Paulo, Brazil, 04012-909
3
Split Clinical Hospital Center
Split, Croatia, 21000
4
University Hospital Dubrava Avenija Gojka Šuška 6
Zagreb, Croatia, 10000