NCT04275726 LANDMARK Trial: a Randomised Controlled Trial of Myval THV
| NCT ID | NCT04275726 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meril Life Sciences Pvt. Ltd. |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 988 participants |
| Start Date | 2020-11-04 |
| Primary Completion | 2024-03-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 988 participants in total. It began in 2020-11-04 with a primary completion date of 2024-03-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)
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 Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices. Exclusion Criteria: 1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study. 2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.
Contact & Investigator
Andreas Baumbach, MD,FESC,FRCP
STUDY CHAIR
Barts Heart Center, London, UK
Frequently Asked Questions
Who can join the NCT04275726 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04275726 currently recruiting?
Yes, NCT04275726 is actively recruiting participants. Contact the research team at ashok.thakkar@merillife.com for enrollment information.
Where is the NCT04275726 trial being conducted?
This trial is being conducted at Minsk, Belarus, São Paulo, Brazil, Split, Croatia, Zagreb, Croatia and 11 additional locations.
Who is sponsoring the NCT04275726 clinical trial?
NCT04275726 is sponsored by Meril Life Sciences Pvt. Ltd.. The principal investigator is Andreas Baumbach, MD,FESC,FRCP at Barts Heart Center, London, UK. The trial plans to enroll 988 participants.