NCT03842397 - OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 30, 2017

Primary Completion Date

July 2, 2018

Study Completion Date

November 28, 2018

Conditions

Mitral Valve Regurgitation

Interventions

DEVICE

Kephalios Device 1

The Kephalios Device 1 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 the Kephalios Device 1 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 (1)

1090

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