Mitral Leaflet Prolapse Clinical Trial
Official title:
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
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.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | March 2013 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | HSR | Milano |
| Lead Sponsor | Collaborator |
|---|---|
| Valtech Cardio Ltd |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Primary | 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 | No |
| Secondary | Incidence of Major Adverse Events (MAE). | 30 days, and 6 months | Yes |