Comparing Myval THV with Contemporary Valves for Aortic Valve Stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The LANDMARK Trial is a randomized controlled trial designed to evaluate the safety and effectiveness of the Myval THV Series compared to contemporary valves, specifically the Sapien and Evolut THV Series, in patients suffering from severe symptomatic native aortic valve stenosis. This multicentric, open-label trial will enroll a total of 768 subjects, with participants randomly assigned in a 1:1 ratio to receive either the Myval THV or one of the contemporary valves. The study aims to assess outcomes through a transfemoral approach and includes a nested registry for patients requiring extra-large valve sizes. The trial will also involve a lead-in set for initial cases to ensure proper implantation techniques.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Dante Pazanesse
  São Paulo, Brazil Recruiting
• Split Clinical Hospital Center
  Split, Croatia Recruiting
• University Hospital Dubrava Avenija Gojka Šuška 6
  Zagreb, Croatia Recruiting
• North Estonia Medical Center
  Tallinn, Estonia Recruiting
• Hôpital Henri Mondor
  Créteil, France Recruiting
• Lille University
  Lille, France Recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Ashok Thakkar, PhD
• Email: ashok.thakkar@merillife.com
• Phone: +91-9879443584

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.