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Recruiting Not applicable NCT04275726

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

No applicable phase (e.g. observational)
Conditions: Aortic Valve Stenosis

Sponsor: Meril Life Sciences Pvt. Ltd.

trial.available_in: БГ
Overview
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)
Description
LANDMARK Trial is a prospective, randomised, multinational, multicentric, open-label non-inferiority trial of total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) with severe symptomatic native aortic valve stenosis via transfemoral approach. * Device sizes applicable for the Myval THV Series: 20 mm, 21.5 mm, 23 mm, 24.5 mm, 26 mm, 27.5 mm, and 29 mm diameter. * Device sizes applicable for the Sapien 3 THV Series: 20 mm, 23 mm, 26 mm, and 29 mm diameter. * Device sizes applicable for the Evolut THV Series: 23 mm, 26 mm, 29 mm, and 34 mm diameter. A non-randomised nested registry will be conducted to include patients requiring extra-large size of Myval THV series (XL Nested Registry) \- Device sizes applicable for the XL Nested Registry: 30.5 mm and 32 mm. A non-randomized registry will include patients implanted with the Myval THV Series (Lead-in Set). \- The investigators have to perform a minimum of 2 lead-in cases (non-randomised) under the guidance of the lead-in evaluation committee.
Who can participate
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 15
Belarus (1)
Republican Scientific-Practical Centre "Cardiology"
Minsk
NOT_YET_RECRUITING
Dr. Oleg Polonetsky, MD, PhD
Brazil (1)
Hospital Dante Pazanesse
São Paulo
Croatia (1)
Split Clinical Hospital Center
Split
Dr. Ivica Kristic, MD, PhD
Estonia (1)
North Estonia Medical Center
Tallinn
France (1)
Hôpital Henri Mondor
Créteil
Prof. Emmanuel Teiger
Germany (1)
Kerckhoff-KlinikForschungs GmbH
Bad Nauheim , Hesse
Greece (1)
Hippkration Hospital
Athens
Prof. Konstantinos Toutouzas
Hungary (1)
Semmelweis University
Budapest
Prof. Bela Merkely, MD Ph. D
Italy (1)
University of Bologna Policlinico S. Orsola-Malpigh
Bologna
NOT_YET_RECRUITING
Dr. Francesco Saia
Netherlands (1)
St Antonius Hospital
Nieuwegein , Dutch
Dr. B.J.W.M Rensing, Cardiologist
New Zealand (1)
Auckland City Hospital 2 Park Road
Grafton , Auckland
Poland (1)
John Paul II Hospital
Krakow , Małopolskie Województwo
NOT_YET_RECRUITING
Slovakia (1)
University hospital Banska Bystrica Námestie Ludvíka Svobodu 1
Banská Bystrica
Spain (1)
Hospital Universitari Son Espases Carretera de Valldemossa
Palma de Mallorca , Balearic Islands
Sweden (1)
Sahlgrenska University Hospital
Gothenburg
Dr. Oskar Angreas
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.11.2020
Completion date
31.12.2033
Registry ID
NCT04275726
Source
anzctr
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