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ClinicalTrials.gov ID

NCT06861361

Lead Sponsor

Ceric SàrlINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,180Estimated

Last Update Posted

May 12, 2026Actual

Start Date

May 15, 2025Actual

Primary Completion Date

Sep 2028Estimated

Completion Date

Sep 2037Estimated

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

Brief 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.

Detailed Description

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

• Myval balloon-expandable THV Series
• Surgical bioprosthetic valve

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Ceric SàrlINDUSTRY

Collaborators

European Cardiovascular Research CenterNETWORK

eric.vanbelle@chu-lille.fr+33 3 20 44 53 01

inedel@yahoo.com+40722742943

david.meier@chuv.ch+41 79 556 38 33