At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Myval balloon-expandable THV Series (device), Surgical bioprosthetic valve (device)
- How long the study runs
- Study runs about 148 months (dates as stated)
- About the drug or intervention
- Myval balloon-expandable THV Series — device: Patients receive Myval balloon-expandable THV Series (TAVR) · Surgical bioprosthetic valve — device: Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at two ways of replacing a narrow heart valve (the aortic valve) in people aged 65 to 75 with severe aortic stenosis, a condition where the valve becomes stiff and narrowed and causes symptoms. It compares open-heart surgery, called surgical aortic valve replacement (SAVR), with a keyhole procedure through a blood vessel in the leg, called transcatheter aortic valve replacement (TAVR). The sponsor is Ceric Sàrl.
Who can take part
- Aged between 65 and 75
- Severe aortic stenosis that causes symptoms (narrowing of the aortic valve shown by specific pressure or speed measurements on a heart scan)
- Heart problems caused by severe calcium build-up on the aortic valve, where a heart team including a heart surgeon agrees that either surgery or the keyhole procedure is suitable
- Agreeing in writing to take part
Who may not be able to
- Cannot understand or follow the study instructions
- Expected to live less than 1 year
- Allergic or very sensitive to aspirin, clopidogrel, or any part of the device
- Under legal protection such as tutorship or curatorship
- Taking part in another trial before the main result is measured
What taking part involves
- • Replacement of the aortic valve either by open-heart surgery (SAVR) or by a tube inserted through a leg artery (TAVR) — the trial team will decide which applies
Time commitment: Not stated — ask the trial team about study visits, duration, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 65 Years to 75 Years
- Who
- All
- Number of participants
- 1,180
- Started
- 2025-05-15
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for symptomatic severe aortic stenosis
- • NA - 1,180 participants
- • 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
Who can take part?
- • Ages 65 Years to 75 Years
- • Diagnosed with symptomatic severe aortic stenosis
Where?
- • Belfast - Royal Victoria Hospital
- • Brighton - University Hospital Sussex NHS foundation Trust
- • Cambridge - Royal Papworth Hospital
- • Cottingham - Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
- • +6 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Prospective, randomized, multinational, multicenter, open label, trial of 1180 patients treated with surgical bioprosthetic aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 65 Years - 75 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Participant will be included if all the following criteria are met:
- ✓Patients aged ≥65 and ≤75
- ✓causing symptoms severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity\>4m/sec).
Who cannot take part
- ✗Participant will not be included if any one of the following conditions exists:
- ✗Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical...
- ✗Life expectancy less than 1 year
- ✗Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components.
- ✗Under judicial protection, tutorship, or curatorship
See the full criteria
Where Is This Study? (10 UK sites)
Royal Victoria Hospital
Belfast, United Kingdom
University Hospital Sussex NHS foundation Trust
Brighton, United Kingdom
Royal Papworth Hospital
Cambridge, United Kingdom
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
Cottingham, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
Barts Heart Centre
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Sheffield Teaching Hopitals NHS Foundation Trust
Sheffield, United Kingdom
Morriston Hospital
Swansea, United Kingdom
How to Get in Touch
Philippe Garot, MD
Sponsor contactCONTACT
Marie-Claude Morrice, MD
Sponsor contactCONTACT
