KALIOS is indicated for the surgical treatment of mitral regurgitation by mitral valve repair.It is intended for mitral valve repair using conventional open heart or minimally invasive techniques. The KALIOS device 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 The primary objective of this clinical investigation is to assess the safety and effectiveness of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s) The secondary objectives are to investigate the effects of KALIOS for the surgical treatment of Mitral Regurgitation on cardiac function and on patient functional status This clinical trial is prospective, non-randomized, single arm, multicentric \& international. Up to 100 patients are expected to be enrolled to obtain 62 evaluable patients at one year,presenting with primary (degenerative) or secondary (functional) mitral valve regurgitation and who are candidate to a mitral valve repair.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
Vienna, Austria
RECRUITINGUniversity Clinic of Cardiac Surgery, Heart Center
Leipzig, Germany
RECRUITINGKlinikum Passau
Passau, Germany
RECRUITINGMaria Cecilia Hospital Cotignola
Cotignola, Italy
RECRUITINGCareggi Hospital
Florence, Italy
RECRUITINGHumanitas Research Hospital
Milan, Italy
NOT_YET_RECRUITINGOspedale Luigi Sacco
Milan, Italy
NOT_YET_RECRUITINGMaria Eleonora Hospital Palermo
Palermo, Italy
RECRUITINGCentre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
NOT_YET_RECRUITINGAssessment of the effectiveness of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s)
Absence of Mitral Regurgitation of grade \> 2 (through echographic assessment)
Time frame: At 1 year
Assessment of the safety of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s)Regurgitation with optional intra-operative and/or post-operative adjustment(s)
Incidence of Major Adverse Cardiac Events (MACE)
Time frame: At 1 year
Assessment of the effectiveness of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s) at each follow up
Absence of Mitral Regurgitation of grade \> 2 (through echographic assessment)
Time frame: at 1, 3 6, 24, 36, 48 and 60 months
Assessment of the adjustment functionality of the device
Assessment of mitral leaflets coaptation (through echographic assessment)
Time frame: immediately after annuloplasty, at 1, 3, 6, 12, 24, 36, 48 and 60 months
Assessment of the adjustment functionality of the device
Assessment of the increase of mitral leaflets coaptation length (through echographic assessment)
Time frame: after any optional adjustment(s) performed immediately after annuloplasty, or following follow up visits at 1, 3, 6, 12, 24, 36, 48 and 60 months
Assessment of the safety of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s)at each follow up
Incidence of Major Adverse Cardiac Events (MACE)
Time frame: at 1, 3, 6, 24, 36, 48 and 60 months
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