Cardiovascular Diseases
Conditions
Keywords
Heart Valve Diseases, Heart failure, Heart diseases, Mitral valve insufficiency
Brief summary
The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair technique as compared with conventional open-heart on-pump mitral valve surgery in patients with severe primary mitral regurgitation.
Interventions
DEVICENeoChord beating heart mitral valve implantation
The NeoChord DS1000 procedure is performed in five steps: (1) Device Preparation; (2) Left Ventricular Access; (3) Leaflet Capture and Verification; (4) Suture Deployment and (5) Suture Closure. The sutures are placed via a ventriculotomy 2-4 cm postero-lateral from the apex of the left ventricle via thoracotomy. The procedure is performed on a beating heart through a 2 to 3 inch right antero-lateral thoracotomy, then one to five Goretex neochordae are introduced with a transcatheter delivery system through the apex of the heart, into the left ventricle, and fixed on the free edge of the prolapsed leaflet. This is performed with transesophageal echocardiographic guidance.
PROCEDUREControl
traditional mitral valve repair performed under cardiac arrest
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe primary mitral regurgitation (grade 3+ or 4+) * Class I indication for MV Surgery according to ESC/EACTS and AHA/ACC guidelines: 1. Symptomatic patients and/or 2. LV (Left Ventricular) dysfunction : LVESD ≥45 mm and/or 30≤ LVEF ≤60% * Leaflet prolapse of P2 and/or A2 * Predicted coaptation length \> 4 mm * Candidates for surgical mitral valve repair according to heart team * Patient able to sign an informed consent form * Patient benefiting from a social insurance system or a similar system
Exclusion criteria
* Asymptomatic patients with preserved LV function * Complex mechanism of MR (leaflet perforation, severe calcifications, commissural extension, etc) * Secondary MR * Predicted post-repair coaptation length less than 4 mm * Atrial fibrillation * Inflammatory or infective valve disease * Severe LV dilation (DTD \> 65 mm) * Significant mitral annulus dilatation (D \> 45 mm) * Surgical indication of tricuspid annulus * Contraindication to TEE (transesophageal echocardiographic ) or inadequate image quality * Need for any other concomitant cardiac procedure * Concurrent medical condition with a life expectancy of less than 24 months * Patient unable to understand the purpose of the trial * Patient \< 18 years old * Participation to another trial that would interfere with this trial * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined incidence of Death from any cause, redo surgery for valve dysfunction, and moderate-severe (3+) or severe (4+) mitral regurgitation | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional evaluation (6 minute walk test ) | 12 months | — |
| Overall survival | 12 months | — |
| Mitral valve reoperation free survival | 12 months | — |
| mitral regurgitation > 2+ | 12 months | — |
| Change in functional evaluation (NYHA) | 12 months | — |
| Proportion of patients with any major adverse events | 30 days | Major adverse events defined by death all cause, Post-operative myocardial infarction, Reoperation for failed surgical repair or valve replacement, Any reoperation or intervention for adverse events (Bleeding…), stoke, renal failure, wound infection, septicemia, ventilation \> 24 hours, transfusion ≥ 2 units |
| Change in quality of life score | 12 months | by using the EQ-5D questionnaire ( European Quality of Life-5 Dimensions) instrument |
| Number of device success | 30 days | — |
| Freedom from rehospitalization for heart failure | 12 months | — |
Countries
France
Outcome results
None listed