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.
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Basel
(BASEC)
Sponsor
HeiMon GmbH Coteau des Ifs 2, CH-1400 Cheseaux-Noréaz
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
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)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
16.05.2024
(BASEC)
ICTRP Studien-ID
NCT04275726 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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)
Öffentlicher Titel
LANDMARK Trial: a Randomised Controlled Trial of Myval THV (ICTRP)
Untersuchte Krankheit(en)
nicht verfügbar
Untersuchte Intervention
nicht verfügbar
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
nicht verfügbar
nicht verfügbar
Primäre und sekundäre Endpunkte
nicht verfügbar
nicht verfügbar
Registrierungsdatum
04.02.2020 (ICTRP)
Einschluss des ersten Teilnehmers
05.11.2020 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
nicht verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/show/NCT04275726 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar