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Taking people in SwitzerlandNo phase

Comparing a catheter-placed heart valve with open surgery for severe aortic stenosis

Compares the Myval valve with surgical valve replacement in people with symptomatic severe aortic stenosis.

Key facts

Who runs it
Ceric Sàrl
Where
Lausanne, SwitzerlandSee the siteAlso in 13 other countries, 48 sites
Trial code
Registry title
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
Status
Recruiting
People taking part
1,180 people, planned
Started
15 May 2025
Expected to end
Sept 2037
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Myval balloon-expandable THV Series
  • Surgical bioprosthetic valve
Record updated
12 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 65 to 75 with severe narrowing of the aortic heart valve that causes symptoms. It compares a valve placed through a tube in a leg artery (Myval) with open-heart surgical valve replacement.

Age
65 to 75 years
Sex
All sexes
Disease stage
Symptomatic severe aortic stenosis caused by calcium build-up on the person's own valve (mean gradient ≥40mmHg and/or peak velocity >4m/sec). A heart team including a cardiac surgeon must agree that both surgery (SAVR) and a valve placed through the leg artery (transfemoral TAVR) are possible.

Main reasons for not taking part

  • Expected to live less than 1 year
  • Known allergy to aspirin, clopidogrel or any part of the valve frame
  • Unable to understand or follow the study instructions
  • Under legal guardianship or court protection
  • Taking part in another trial before the main result is measured

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Participant will be included if all the following criteria are met:
  • Patients aged ≥65 and ≤75
  • Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity>4m/sec)
  • 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

Who cannot take part

  • Participant will not be included if any one of the following conditions exists:
  • Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components
  • Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol
  • Life expectancy less than 1 year
  • Under judicial protection, tutorship, or curatorship
  • Participation in another trial before the primary endpoint

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 65 and 75 years old?

Where in Switzerland

Also in 13 other countries, 48 sites

  • CHUVLausanne, SwitzerlandContact: David Meier, MDTaking people

About the trial

What the trial wants to find out

The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.

The 2 groups in the trial

  • TAVR: Myval balloon-expandable THV SeriesTreatment being tested

    Myval balloon-expandable THV Series will be used for valve replacement

    Treatment: Myval balloon-expandable THV Series

  • SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation siteExisting treatment, for comparison

    Surgical bioprosthetic valve commercially available at the clinical investigation site will be used for valve replacement

    Treatment: Surgical bioprosthetic valve

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Surgical Bioprosthesis Aortic Valve Replacement Vs. Myval Balloon-Expandable THV Series in Patients Aged 65 to 75 With Symptomatic Severe Aortic Stenosis Judged Eligible by Heart Team
Plain-language title
Comparing a catheter-placed heart valve with open surgery for severe aortic stenosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06861361, who can take part
Publications
Record updated
12 May 2026