LANDMARK Trial: a Randomised Controlled Trial of Myval THV
Recruiting now · Not applicable
Conditions studied: Aortic Valve Stenosis
In brief
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)
Key facts
- Study ID
- NCT04275726
- Run by
- Meril Life Sciences Pvt. Ltd.
- People needed
- 988
- Starts
- 2020-11-04
- Expected to finish
- 2033-12-31
- Last updated by the study team
- 2025-04-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Amphia Ziekenhui Hospital — Breda, Netherlands (enrolling)
- University Medical Center Utrecht — Utrecht, Netherlands (enrolling)
- Clinical Institute Saint Ambrogio — Milan, Italy (enrolling)
- Radboud University Nijmegen — Nijmegen, Gelderland, Netherlands (enrolling)
- Hôpital Henri Mondor — Créteil, France (enrolling)
- Split Clinical Hospital Center — Split, Croatia (enrolling)
- University Hospital Dubrava Avenija Gojka Šuška 6 — Zagreb, Croatia (enrolling)
- Arnault Tzanck Institute — Nice, France (enrolling)
- North Estonia Medical Center — Tallinn, Estonia (enrolling)
- St Antonius Hospital — Nieuwegein, Dutch, Netherlands (enrolling)
- Leipzig Heart Institute GmbH — Leipzig, Saxony, Germany (enrolling)
- University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15 — Bad Krozingen, Germany (enrolling)
- Lille University — Lille, France (enrolling)
- Technology University Dresden Fetscherstraße 76 — Dresden, Germany (enrolling)
- Institut Cardiovascular Paris-Sud — Massy, France (enrolling)
- Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg — Regensburg, Germany (enrolling)
- Hippkration Hospital — Athens, Greece (enrolling)
- Hygeia hospital — Marousi, Greece (enrolling)
- Interbalkan European Medical Center — Thessaloniki, Greece (enrolling)
- Semmelweis University — Budapest, Hungary (enrolling)
- Kerckhoff-KlinikForschungs GmbH — Bad Nauheim, Hesse, Germany (enrolling)
- Hospital Dante Pazanesse — São Paulo, Brazil (enrolling)
- San Donato Hospital — Milan, Italy (enrolling)
- San Raffaele Hospital — Milan, Italy (enrolling)
- Auckland City Hospital 2 Park Road — Grafton, Auckland, New Zealand (enrolling)
Full record on ClinicalTrials.gov
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