OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation

NAUnknownINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 20, 2019

Primary Completion Date

May 31, 2021

Study Completion Date

May 31, 2025

Conditions
Mitral Valve Regurgitation
Interventions
DEVICE

Kalios Implant

KALIOS is an adjustable annuloplasty ring, to be implanted by open surgery, having a hollow structure that comprises a flat rigid ring surrounding a deformable cage. The unique feature of KALIOS is that its annular shape and dimension can be finely adjusted percutaneously by an external actuator (three-balloon catheter) independently in the three areas corresponding to P1, P2 and P3

Trial Locations (9)

50134

RECRUITING

Careggi Hospital, Florence

Unknown

RECRUITING

Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery, Vienna

RECRUITING

University Clinic of Cardiac Surgery, Heart Center, Leipzig

RECRUITING

Klinikum Passau, Passau

RECRUITING

Maria Cecilia Hospital Cotignola, Cotignola

NOT_YET_RECRUITING

Humanitas Research Hospital, Milan

NOT_YET_RECRUITING

Ospedale Luigi Sacco, Milan

RECRUITING

Maria Eleonora Hospital Palermo, Palermo

NOT_YET_RECRUITING

Centre Hospitalier Universitaire Vaudois, Lausanne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Kephalios

INDUSTRY