LANDMARK Trial: a Randomised Controlled Trial of Myval THV
Recruiting
N/A
Interventional Study
Aortic Valve Stenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 988 (estimated)
- Sponsor
- Meril Life Sciences Pvt. Ltd. · Industry
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About This Trial
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 allocat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patient ≥18 years of age.
2. 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.
3. As per local Heart Tea…
Contacts