LANDMARK Trial: a Randomised Controlled Trial of Myval THV (LANDMARK)
Aortic Valve Stenosis
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring LANDMARK Trial, Trial to evaluate safety & effectiveness of Myval THV, CE Approved Myval THV Series
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Republican Scientific-Practical Centre "Cardiology"
- Hospital Dante PazanesseRecruiting
- Split Clinical Hospital CenterRecruiting
- University Hospital Dubrava Avenija Gojka Šuška 6Recruiting
- North Estonia Medical CenterRecruiting
- Hôpital Henri MondorRecruiting
- Lille UniversityRecruiting
- Institut Cardiovascular Paris-Sud
- Arnault Tzanck InstituteRecruiting
- Centre Hospitalier Universitaire De Rennes
- Kerckhoff-KlinikForschungs GmbH
- Leipzig Heart Institute GmbH
- University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15
- Klinikum Braunschweig Freisestre
- Technology University Dresden Fetscherstraße 76
- Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5
- Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg
- Hippkration HospitalRecruiting
- Interbalkan European Medical CenterRecruiting
- Semmelweis UniversityRecruiting
- University of Bologna Policlinico S. Orsola-Malpigh
- Policlinico di Catania
- San Raffaele HospitalRecruiting
- Clinical Institute Saint Ambrogio Via Luigi Giuseppe Faravelli
- San Donato HospitalRecruiting
- Mauriliano Hospital Largo Filippo
- University Hospital Città della Salute e della Scienza Turin Bramante
- St Antonius HospitalRecruiting
- Radboud University NijmegenRecruiting
- Isala Zwolle Hospital
- Onze lieve vrouwe gasthuis Oosterperk 9
- Amphia Ziekenhui HospitalRecruiting
- University Medical Center (UMC)
- University Medical Center UtrechtRecruiting
- Auckland City Hospital 2 Park RoadRecruiting
- John Paul II Hospital
- University of Gdansk
- Medical University of Silesia
- Institute of Cardiology
- Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58Recruiting
- Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos SantosRecruiting
- Hospital de Santa Maria, Av. Prof. Egas Moniz MB
- Centro Hospital Lisboa Central E.P.E. - Santa Marta
- Centro Hospitalar de Sao Joao
- University hospital Banska Bystrica Námestie Ludvíka Svobodu 1Recruiting
- University Medical Center, LjubljanaRecruiting
- Hospital Universitario de Gran Canaria Dr NegrinRecruiting
- Hospital Universitari Son Espases Carretera de ValldemossaRecruiting
- Hospital Universitario Renei SofiaRecruiting
- Hospital Clínico San Carlos
- Hospital Cliinico Univertistario de ValladolidRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Myval THV Series
Contemporary Valves
Myval THV Series will include Myval/Myval Inception THVs or any subsequent advanced version commercially available at the study site. This treatment arm will be assigned to 384 / 768 subjects enrolled in a study.
Sapien THV Series will consist of Sapien 3/Sapien 3 Ultra THVs or any subsequent advanced version commercially available at the study site. Evolut THV Series will include Evolut R/Evolut PRO THVs or any subsequent advanced version commercially available at the study site. This treatment arm will be assigned to 384 / 768 subjects enrolled in a study.