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Surgical vs Transcatheter Aortic Valve Replacement in Young Patients

NCT ID: NCT06861361

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2031-11-30

Brief Summary

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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

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Prospective, randomized, multinational, multicenter, open label, trial of 1180 patients treated with surgical bioprosthetic aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).

Conditions

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Symptomatic Severe Aortic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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TAVR: Myval balloon-expandable THV Series

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

Group Type EXPERIMENTAL

Myval balloon-expandable THV Series

Intervention Type DEVICE

Patients receive Myval balloon-expandable THV Series (TAVR)

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

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

Group Type ACTIVE_COMPARATOR

Surgical bioprosthetic valve

Intervention Type DEVICE

Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)

Interventions

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Myval balloon-expandable THV Series

Patients receive Myval balloon-expandable THV Series (TAVR)

Intervention Type DEVICE

Surgical bioprosthetic valve

Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ceric Sàrl

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Lille

Lille, , France

Site Status RECRUITING

Infirmerie Protestante de Lyon

Lyon, , France

Site Status RECRUITING

Massy-Hôpital Jacques Cartier

Massy, , France

Site Status RECRUITING

CHU de Rouen

Rouen, , France

Site Status NOT_YET_RECRUITING

Clinique Pasteur

Toulouse, , France

Site Status RECRUITING

Hospital clínico universitario de Valladolid

Valladolid, , Spain

Site Status RECRUITING

CHUV

Lausanne, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Countries

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France Spain Switzerland

Facility Contacts

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Van Belle

Role: primary

Esteve

Role: primary

Garot

Role: primary

Eltchaninoff

Role: primary

Tchetche

Role: primary

Amat Santos

Role: primary

References

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Milojevic M, Myers PO, Falk V, Bavaria JE, Borger MA, Casselman FPA, Badhwar V, Kaul S, Siepe M, Sadaba JR. Methodological Appraisal of Ongoing Trial of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Younger Patients: From Incentives to Guideline-Informing Evidence. Eur J Cardiothorac Surg. 2025 Dec 1;67(12):ezaf348. doi: 10.1093/ejcts/ezaf348.

Reference Type DERIVED
PMID: 41351226 (View on PubMed)

Other Identifiers

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START YOUNG

Identifier Type: -

Identifier Source: org_study_id