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Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

NCT06861361 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1180

Last updated 2026-05-12

No results posted yet for this study

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

Interventions

DEVICE

Myval balloon-expandable THV Series

Patients receive Myval balloon-expandable THV Series (TAVR)

DEVICE

Surgical bioprosthetic valve

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

Sponsors & Collaborators

  • European Cardiovascular Research Center

    collaborator NETWORK

  • Ceric Sàrl

    lead INDUSTRY

Principal Investigators

  • Philippe Garot · European Cardiovascular Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2028-09-30
Completion
2037-09-30

Countries

  • Austria
  • Estonia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Slovenia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06861361 on ClinicalTrials.gov