MITRACHORD: 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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02829749

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Device: NeoChord beating heart mitral valve implantation Procedure: Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NeoChord DS1000 Artificial Chordae Delivery System Subjects randomized to the experimental group will undergo the NeoChord implantation	Device: NeoChord 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.
Other: Control traditional mitral valve repair performed under cardiac arrest	Procedure: Control traditional mitral valve repair performed under cardiac arrest

Arm

Intervention/Treatment

Experimental: NeoChord DS1000 Artificial Chordae Delivery System

Subjects randomized to the experimental group will undergo the NeoChord implantation

Device: NeoChord 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.

Other: Control

traditional mitral valve repair performed under cardiac arrest

Procedure: Control

traditional mitral valve repair performed under cardiac arrest

Outcome Measures

Primary Outcome Measures

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

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
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 [12 months]
by using the EQ-5D questionnaire ( European Quality of Life-5 Dimensions) instrument
Number of device success [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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