The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" . The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.
HSR
Milan, Italy
Technical success rate
ability to: 1. Anchor the system in the papillary muscle; 2. Suture the leaflet; 3. Release the V-Chordal system and extract the delivery system with no lesions to adjacent tissue. 4. Technical feasibility of chordal length adjustment. When required, adjustment of chords after weaning from CPB
Time frame: 6 months
Efficacy
The ability of the V-Chordal System to correct leaflet prolapse of the treated segments as assessed by echordiography. Correction is defined as leaflet displacement \<2 mm above the annulus in the septolateral view.
Time frame: 30 days and 6 months
Incidence of Major Adverse Events (MAE).
Time frame: 30 days, and 6 months
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