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LANDMARK Trial: a Randomised Controlled Trial of Myval THV
Sponsor: Meril Life Sciences Pvt. Ltd.
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)
Official title: A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
988
Start Date
2020-11-04
Completion Date
2033-12-31
Last Updated
2025-04-04
Healthy Volunteers
No
Conditions
Interventions
Myval THV Series
The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.
Contemporary Valves (Sapien THV Series and Evolut THV Series)
The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.
Locations (54)
Republican Scientific-Practical Centre "Cardiology"
Minsk, Belarus
Hospital Dante Pazanesse
São Paulo, Brazil
Split Clinical Hospital Center
Split, Croatia
University Hospital Dubrava Avenija Gojka Šuška 6
Zagreb, Croatia
North Estonia Medical Center
Tallinn, Estonia
Hôpital Henri Mondor
Créteil, France
Lille University
Lille, France
Institut Cardiovascular Paris-Sud
Massy, France
Arnault Tzanck Institute
Nice, France
Centre Hospitalier Universitaire De Rennes
Rennes, France
Kerckhoff-KlinikForschungs GmbH
Bad Nauheim, Hesse, Germany
Leipzig Heart Institute GmbH
Leipzig, Saxony, Germany
University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15
Bad Krozingen, Germany
Klinikum Braunschweig Freisestre
Braunschweig, Germany
Technology University Dresden Fetscherstraße 76
Dresden, Germany
Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5
Hamburg, Germany
Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg
Regensburg, Germany
Hippkration Hospital
Athens, Greece
Hygeia hospital
Marousi, Greece
Interbalkan European Medical Center
Thessaloniki, Greece
Semmelweis University
Budapest, Hungary
University of Bologna Policlinico S. Orsola-Malpigh
Bologna, Italy
Policlinico di Catania
Catania, Italy
San Donato Hospital
Milan, Italy
San Raffaele Hospital
Milan, Italy
Clinical Institute Saint Ambrogio
Milan, Italy
Mauriliano Hospital Largo Filippo
Tortona, Italy
University Hospital Città della Salute e della Scienza Turin Bramante
Turin, Italy
St Antonius Hospital
Nieuwegein, Dutch, Netherlands
Radboud University Nijmegen
Nijmegen, Gelderland, Netherlands
Isala Zwolle Hospital
Zwolle, Overijssel, Netherlands
Onze lieve vrouwe gasthuis Oosterperk 9
Amsterdam, Netherlands
Amphia Ziekenhui Hospital
Breda, Netherlands
University Medical Center (UMC)
Groningen, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Auckland City Hospital 2 Park Road
Grafton, Auckland, New Zealand
John Paul II Hospital
Krakow, Małopolskie Województwo, Poland
University of Gdansk
Gdansk, Pomorskie Województwo, Poland
Medical University of Silesia
Katowice, Prussian, Poland
Institute of Cardiology
Warsaw, Poland
Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58
Wroclaw, Poland
Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos Santos
Carnaxide, Portugal
Centro Hospital Lisboa Central E.P.E. - Santa Marta
Lisbon, Portugal
Hospital de Santa Maria, Av. Prof. Egas Moniz MB
Lisbon, Portugal
Centro Hospitalar de Sao Joao
Porto, Portugal
University hospital Banska Bystrica Námestie Ludvíka Svobodu 1
Banská Bystrica, Slovakia
University Medical Center, Ljubljana
Ljubljana, Slovenia
Hospital Universitari Son Espases Carretera de Valldemossa
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario de Gran Canaria Dr Negrin
Las Palmas, Canary Islands, Spain
Hospital Universitario Renei Sofia
Córdoba, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Cliinico Univertistario de Valladolid
Valladolid, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
Uppsala University Hospital
Uppsala, Sweden