V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse

Study Overview
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Brief Summary
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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.

Official Title
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V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse

Conditions
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Mitral Leaflet Prolapse

Intervention / Treatment
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* Device: V Chordal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: V 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | ability to: Anchor the system in the papillary muscle; Suture the leaflet; Release the V-Chordal system and extract the delivery system with no lesions to adjacent tissue. Technical feasibility of chordal length adjustment. When required, adjustment of chords after weaning from CPB | 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. | 30 days and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Major Adverse Events (MAE). |  | 30 days, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart disease, Device, Mitral valve, leaflet prolapse, Heart valve disease, Cardiovascular disease, Neochordae