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.
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Basilea
(BASEC)
Sponsor
HeiMon GmbH Coteau des Ifs 2, CH-1400 Cheseaux-Noréaz
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
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)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
16.05.2024
(BASEC)
ID di studio ICTRP
NCT04275726 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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)
Titolo pubblico
LANDMARK Trial: a Randomised Controlled Trial of Myval THV (ICTRP)
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
04.02.2020 (ICTRP)
Inclusione del primo partecipante
05.11.2020 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/show/NCT04275726 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile