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.
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
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)
Trial sites
Basel
(BASEC)
Sponsor
HeiMon GmbH Coteau des Ifs 2, CH-1400 Cheseaux-Noréaz
(BASEC)
Contact
Contact Person Switzerland
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)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
16.05.2024
(BASEC)
ICTRP Trial ID
NCT04275726 (ICTRP)
Official title (approved by ethics committee)
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)
Academic title
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)
Public title
LANDMARK Trial: a Randomised Controlled Trial of Myval THV (ICTRP)
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
04.02.2020 (ICTRP)
Incorporation of the first participant
05.11.2020 (ICTRP)
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/show/NCT04275726 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available