RecruitingNot Applicable

Surgical vs Transcatheter Aortic Valve Replacement in Young Patients

France1,180 participantsStarted 2025-05-15

Plain-language summary

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 participate

Age range65 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol
✕. Life expectancy less than 1 year
✕. Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components.
✕. Under judicial protection, tutorship, or curatorship
✕. Participation in another trial before the primary endpoint

What they're measuring

Primary safety endpoint at 1 month (non-inferiority): Composite measure of all-cause death, any stroke, bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or or reintervention for aortic valve dysfunction.

Timeframe: 1 month post procedure

Primary efficacy endpoint at 1 year (non-inferiority): Composite measure of all-cause death, any stroke, or rehospitalization for valve related event

Timeframe: 1 year post procedure

CT Scan Sub Study endpoints: primary endpoint : prevalence of feasible redoTAVR or ViV TAVR without requiring leaflet modifications techniques (green cases).

Timeframe: 1 month post procedure

Trial details

NCT IDNCT06861361

SponsorCeric Sàrl

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11

View on ClinicalTrials.gov More Symptomatic Severe Aortic Stenosis trials

Who can participate

Age range65 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol
✕. Life expectancy less than 1 year
✕. Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components.
✕. Under judicial protection, tutorship, or curatorship
✕. Participation in another trial before the primary endpoint

What they're measuring

Timeframe: 1 month post procedure

Primary efficacy endpoint at 1 year (non-inferiority): Composite measure of all-cause death, any stroke, or rehospitalization for valve related event

Timeframe: 1 year post procedure

CT Scan Sub Study endpoints: primary endpoint : prevalence of feasible redoTAVR or ViV TAVR without requiring leaflet modifications techniques (green cases).

Timeframe: 1 month post procedure