Surgical vs Transcatheter Aortic Valve Replacement in Young Patients

NCT06861361 | Recruiting DMC

• 1 other identifier: START YOUNG
• Study Type: interventional
• Target: 1,180
• Locations: 3 countries
• Sites: 7

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.

Conditions

Symptomatic Severe Aortic Stenosis

Outcome Measures

Primary Outcomes (3)

• 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.

  Composite measure of all-cause death, any stroke, VARC-3 type 1 (only overt bleeding that requires a transfusion of 1 unit of whole blood/red blood cells (BARC 3a), type 2 and 3 bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or reintervention for aortic valve dysfunction.

  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

  Composite measure of all-cause death, any stroke, or rehospitalization for valve related event at 1 year (VARC-3 definition)

  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).

  Proportion of participants classified as "green cases" (redo-TAVR or ViV-TAVR feasible without leaflet modification) based on predefined CT scan criteria, including annular dimensions, coronary access, and valve frame interactions.

  1 month post procedure

Secondary Outcomes (23)

• Secondary Endpoint: Individual components of the primary endpoints: all cause mortality over time

  1, 2, 3 and 5 years

• Secondary Endpoint: Individual components of the primary endpoints: Stroke Over Time

  1, 2, 3 and 5 years

• Secondary Endpoint: Individual components of the primary endpoints: Bleeding Events (VARC-3 Type 1, 2, and 3) Over Time

  1, 2, 3 and 5 years

• Secondary Endpoint: Individual components of the primary endpoints: Acute Kidney Injury (AKI) Stage 2-4 Over Time

  1, 2, 3 and 5 years

• Secondary Endpoint: Individual components of the primary endpoints: Rehospitalization for Procedure-Related Event Over Time

  1, 2, 3 and 5 years

Study Arms (2)

TAVR: Myval balloon-expandable THV Series

EXPERIMENTAL

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

Device: Myval balloon-expandable THV Series

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

ACTIVE COMPARATOR

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

Device: Surgical bioprosthetic valve

Interventions

Myval balloon-expandable THV Series DEVICE

Patients receive Myval balloon-expandable THV Series (TAVR)

TAVR: Myval balloon-expandable THV Series

Surgical bioprosthetic valve DEVICE

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

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

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Participant will be included if all the following criteria are met:
• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Ceric Sàrl: lead

Study Sites (7)

CHU Lille

Lille, France

RECRUITING

Infirmerie Protestante de Lyon

Lyon, France

RECRUITING

Massy-Hôpital Jacques Cartier

Massy, France

RECRUITING

CHU de Rouen

Rouen, France

NOT YET RECRUITING

Clinique Pasteur

Toulouse, France

RECRUITING

Hospital clínico universitario de Valladolid

Valladolid, Spain

RECRUITING

CHUV

Lausanne, Switzerland

ACTIVE NOT RECRUITING

Related Publications (1)

• 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.

  PMID: 41351226 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 6, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2031
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

ES (1); CH (1); FR (5)