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
- Belgrade and Kamenitz, SerbiaSee the 2 sitesAlso in 13 other countries, 47 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 Serbia
Also in 13 other countries, 47 sites
- University Clinical Center of SerbiaBelgrade, SerbiaContact: Zlatko Mehmedbegovic, MDNot yet recruiting
- Institute of Cardiovascular Diseases of VojvodinaKamenitz, SerbiaContact: Mila Kovačević, 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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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
- Methodological Appraisal of Ongoing Trial of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Younger Patients: From Incentives to Guideline-Informing Evidence.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2025
- Record updated
- 12 May 2026