Surgical versus transcatheter aortic valve replacement for patients aged 65–75

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

This is a prospective, randomized, open-label, multinational trial that will enroll 1,180 patients with symptomatic severe native calcific aortic stenosis aged 65–75. Participants are randomized to receive either a Myval balloon-expandable transcatheter heart valve (transfemoral TAVR) or a surgical bioprosthetic aortic valve replacement (SAVR). The primary objective is to demonstrate non-inferiority of clinical outcomes with the Myval series compared with SAVR as judged by predefined endpoints determined by a multidisciplinary heart team. The trial is being conducted across multiple centers with standard follow-up to compare safety and efficacy between the two approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participant will be included if all the following criteria are met:

1. Patients aged ≥65 and ≤75
2. Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity\>4m/sec).
3. Patients with symptomatic heart disease due to severe native calcific aortic stenosis, as judged by a multidisciplinary heart team (including a cardiac surgeon), for whom SAVR or transfemoral TAVR is deemed feasible and approved by the local heart team.Signed informed consent for participation in the clinical investigation

Exclusion Criteria:

Participant will not be included if any one of the following conditions exists:

1. Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol
2. Life expectancy less than 1 year
3. Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components.
4. Under judicial protection, tutorship, or curatorship
5. Participation in another trial before the primary endpoint

Where it's running

• Medical University of Graz
  Graz, Austria Recruiting
• University Hostpital Sankt Pölten
  Sankt Pölten, Austria Recruiting
• Medical University of Vienna
  Vienna, Austria Recruiting
• North-Estonia Medical Centre Foundation
  Tallinn, Estonia Recruiting
• CHU Lille
  Lille, France Recruiting
• Infirmerie Protestante de Lyon
  Lyon, France Recruiting

Study contacts

• Principal investigator: Philippe Garot — European Cardiovascular Research Center
• Study coordinator: Philippe Garot, MD
• Email: pgarot@angio-icps.com
• Phone: +330160134602

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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.