The Leaflex™ Standalone Study Protocol

NATerminatedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

September 2, 2020

Primary Completion Date

November 20, 2023

Study Completion Date

August 14, 2024

Conditions

Aortic Valve Stenosis

Interventions

DEVICE

Leaflex™ Performer

A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.

Trial Locations (1)

Gottsegen Gyorgy Hungarian Institute of Cardiology, Budapest