Comparison of the safety and efficacy of Meril's Myval transcatheter heart valves (THV) compared to conventional valves (Edwards' Sapien THV and Medtronic's Evolut THV) in patients whose diseased aortic valve needs to be replaced.
Résumé de l'étude
Patients suffering from severe symptomatic native aortic stenosis (a narrowing of the aortic valve) that prevents normal blood flow from the heart will be asked if they would like to participate in the LANDMARK study, which compares the safety and efficacy of the transcatheter heart valves (THV) of Meril Life Sciences Pvt. Ltd.'s Myval series with those of conventional valves (Edwards' Sapien THV and Medtronic's Evolut THV) in patients with severe symptomatic native aortic stenosis. After successful randomization, participation in this study begins on the date of consent and may last up to 10 years after valve implantation. However, participants may decide at any time to end or withdraw from the study. Participants will undergo various follow-up examinations, which will be a mix of clinic visits and phone visits. First visit: hospital visit for valve replacement, further visits are clinical follow-ups at 30 days, 1 year, 3 years, 5 years, 7 years, and 10 years, as well as phone follow-ups at 6 months, 2 years, and 4 years.
(BASEC)
Intervention étudiée
Patients deemed suitable for participation in this study will either be included as a 'Lead-In Case', assigned to the 'XL Registry', or they will be part of the study group that will be randomized only after the principal investigator has successfully completed all 'Lead-In' cases and has been approved by the 'Lead-In Assessment Committee' as an 'independent investigator'. The study group is randomized. 'Randomized' means that participants are assigned to a study treatment randomly, much like flipping a coin. Participants will randomly receive either the study product (Meril's Myval ™ THV series) or the control products (Edwards' SAPIEN THV series and Medtronic's Evolut THV series).
(BASEC)
Maladie en cours d'investigation
Patients whose diseased aortic valve needs to be replaced.
(BASEC)
All patients participating in this study must meet the following inclusion criteria: 1. The patient must be ≥18 years old. 2. The patient has provided written consent approved by the ethics committee to participate in the study. 3. In the opinion of the local heart team, the patient is eligible for TAVI, and the patient is suitable for implantation with all three study devices. (BASEC)
Critères d'exclusion
1. Patients who are not willing to provide informed consent or whose legal heirs oppose their participation in the study. 2. Any condition that, in the opinion of the investigator, would exclude safe participation of the patient in the study. (BASEC)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
HeiMon GmbH Coteau des Ifs 2, CH-1400 Cheseaux-Noréaz
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. med. Thomas Nestelberger
061 328 74 74
Thomas.nestelberger@clutterusb.chUniversitätsspital Basel Universitäres Herzzentrum Gebäudeteil C4, 8. Stock Petersgraben 4 4031 Basel
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
16.05.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT04275726 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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’ Sapien THV series and Medtronic’s Evolut THV series) in patients with severe symptomatic native aortic valve stenosis. (BASEC)
Titre académique
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 (ICTRP)
Titre public
LANDMARK Trial: a Randomised Controlled Trial of Myval THV (ICTRP)
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
04.02.2020 (ICTRP)
Inclusion du premier participant
05.11.2020 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/show/NCT04275726 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible