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Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

Sponsor: Ceric Sàrl

NCT ID: NCT06861361

View on ClinicalTrials.gov ↗

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).

Symptomatic Severe Aortic Stenosis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

met

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
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 Is This Study? (10 UK sites)

Royal Victoria Hospital

Belfast, United Kingdom

NOT_YET_RECRUITING

University Hospital Sussex NHS foundation Trust

Brighton, United Kingdom

Recruiting
Site contact (verified)

Royal Papworth Hospital

Cambridge, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Charis Costopoulos, MDcharis.costopoulos@nhs.net

Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust

Cottingham, United Kingdom

Recruiting
Site contact (verified)

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

Recruiting
Site contact (verified)

Barts Heart Centre

London, United Kingdom

Recruiting
Site contact (verified)
Andreas Baumbach, MDbaumbach.andreas@nhs.net

Imperial College Healthcare NHS Trust

London, United Kingdom

Recruiting
Site contact (verified)
Emad Aljaaly, MDemad.aljaaly@nhs.net

Freeman Hospital

Newcastle upon Tyne, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Sheffield Teaching Hopitals NHS Foundation Trust

Sheffield, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Morriston Hospital

Swansea, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Philippe Garot, MD

Sponsor contact

CONTACT

+330160134602 pgarot@angio-icps.com

Marie-Claude Morrice, MD

Sponsor contact

CONTACT

mcmorice@cerc-europe.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-05