Taking peopleNo phase
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
Key facts
- Who runs it
- Ceric Sàrl
- Where
- Mercogliano, Milan, Parma, Roma, and San Donato Milanese, ItalySee the 6 sitesAlso in 13 other countries, 43 sites
- Trial code
- 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
- Age
- 65 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
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 Italy
Also in 13 other countries, 43 sites
- Montevergine ClinicMercogliano, ItalyContact: Luigi Salemme, MDNot yet recruiting
- Centro Cardiologico Monzino IRCCSMilan, ItalyContact: Federico De Marco, MDNot yet recruiting
- IRCCS Ospedale Galeazzi Sant'AmbrogioMilan, ItalyContact: Alfonso IELASI, MDNot yet recruiting
- Azienda Ospedaliero Universitaria di ParmaParma, ItalyContact: Davide Capodanno, MDNot yet recruiting
- Fondazione Policlinico Campus Bio-Medico di RomaRoma, ItalyContact: Gian Paolo Ussia, MDNot yet recruiting
- IRCCS Policlinico San DonatoSan Donato Milanese, ItalyContact: Luca Testa, MDNot yet recruiting
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
- 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