Mitral Leaflet Prolapse
Conditions
Keywords
Heart disease, Device, Mitral valve, leaflet prolapse, Heart valve disease, Cardiovascular disease, Neochordae
Brief summary
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.
Interventions
DEVICEV Chordal
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.
Sponsors
Edwards Lifesciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines. * Patient able and willing to return to the implant center for follow-up visits * Able and willing to give informed consent and follow protocol procedures.
Exclusion criteria
* Inadequate echocardiographic window for transthoracic imaging * Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus. * Evolving endocarditis or active endocarditis in the last 3 months. * Heavily calcified annulus or leaflets. * Congenital malformation with limited valvular tissue * Patient requires mitral valve replacement. * Previously implanted annuloplasty ring/band. * Patient requires aortic or pulmonic valve replacement or repair. * Patient is pregnant (urine HCG test result positive) or lactating. * Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk. * Life expectancy of less than twelve months. * Patient is participating in concomitant research studies of investigational products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | 6 months | 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 |
| Efficacy | 30 days and 6 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Major Adverse Events (MAE). | 30 days, and 6 months |
Countries
Italy
Outcome results
None listed