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RECRUITING
NCT06861361
NA

Surgical vs Transcatheter Aortic Valve Replacement in Young Patients

Sponsor: Ceric Sàrl

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1180

Start Date

2025-05-15

Completion Date

2031-11

Last Updated

2025-12-18

Healthy Volunteers

No

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)

Locations (7)

CHU Lille

Lille, France

Infirmerie Protestante de Lyon

Lyon, France

Massy-Hôpital Jacques Cartier

Massy, France

CHU de Rouen

Rouen, France

Clinique Pasteur

Toulouse, France

Hospital clínico universitario de Valladolid

Valladolid, Spain

CHUV

Lausanne, Switzerland