Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse

Study Overview
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Brief Summary
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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.

Official Title
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A European, Multicenter, Randomized Study Comparing the Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: NeoChord beating heart mitral valve implantation
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe primary mitral regurgitation (grade 3+ or 4+) Class I indication for MV Surgery according to ESC/EACTS and AHA/ACC guidelines: Symptomatic patients and/or 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

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeoChord DS1000 Artificial Chordae Delivery System<br>Subjects randomized to the experimental group will undergo the NeoChord implantation | Device: NeoChord beating heart mitral valve implantation<br>* 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.<br>|
| Other: Control<br>traditional mitral valve repair performed under cardiac arrest | Procedure: Control<br>* traditional mitral valve repair performed under cardiac arrest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with any major adverse events | 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 | 30 days | 
| Overall survival |  | 12 months | 
| Mitral valve reoperation free survival |  | 12 months | 
| mitral regurgitation > 2+ |  | 12 months | 
| Freedom from rehospitalization for heart failure |  | 12 months | 
| Change in functional evaluation (NYHA) |  | 12 months | 
| Change in functional evaluation (6 minute walk test ) |  | 12 months | 
| Change in quality of life score | by using the EQ-5D questionnaire ( European Quality of Life-5 Dimensions) instrument | 12 months | 
| Number of device success |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Valve Diseases, Heart failure, Heart diseases, Mitral valve insufficiency