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LANDMARK Trial: a Randomised Controlled Trial of Myval THV
LANDMARK Trial: a Randomised Controlled Trial of Myval THV

NCT04275726

RecruitingNA

Sponsor: Meril Life Sciences Pvt. Ltd.

Conditions: Aortic Valve Stenosis

Interventions: Myval THV Series, Contemporary Valves (Sapien THV Series and Evolut THV Series)

Countries: Belarus, Brazil, Croatia, Estonia, France, Germany, Greece, Hungary

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (54)
  • Minsk, Belarus
  • São Paulo, Brazil
  • Split, Croatia
  • Zagreb, Croatia
  • Tallinn, Estonia
  • Créteil, France
  • Lille, France
  • Massy, France
  • Nice, France
  • Rennes, France
  • Bad Nauheim, Hesse, Germany
  • Leipzig, Saxony, Germany
  • Bad Krozingen, Germany
  • Braunschweig, Germany
  • Dresden, Germany
  • Hamburg, Germany
  • Regensburg, Germany
  • Athens, Greece
  • Marousi, Greece
  • Thessaloniki, Greece
  • Budapest, Hungary
  • Bologna, Italy
  • Catania, Italy
  • Milan, Italy
  • Milan, Italy
  • Milan, Italy
  • Tortona, Italy
  • Turin, Italy
  • Nieuwegein, Dutch, Netherlands
  • Nijmegen, Gelderland, Netherlands
  • + 24 more on CT.gov