Surgical vs Transcatheter Aortic Valve Replacement in Young Patients (START YOUNG)

Ceric Sàrl

Status: Enrolling

Conditions: Symptomatic Severe Aortic Stenosis

Treatments: Device: Myval balloon-expandable THV Series; Device: Surgical bioprosthetic valve

Study type: Interventional

Funder types: Industry

Identifiers

NCT06861361

START YOUNG

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,180 estimated patients

Sex: All

Ages: 65 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,180 participants in 2 patient groups

TAVR: Myval balloon-expandable THV Series

Experimental group

Description:

Myval balloon-expandable THV Series will be used for valve replacement

Treatment:

Device: Myval balloon-expandable THV Series

SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation site

Active Comparator group

Description:

Surgical bioprosthetic valve commercially available at the clinical investigation site will be used for valve replacement

Treatment:

Device: Surgical bioprosthetic valve