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 (MITRACHORD)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: NeoChord beating heart mitral valve implantation; Procedure: Control

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Hôpital Louis Pradel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		12 months
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
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jean-François OBADIA, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: July 4, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Heart failure; Heart diseases; Heart Valve Diseases; Mitral valve insufficiency
• Additional Relevant MeSH Terms: Heart Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Cardiovascular Diseases; Mitral Valve Insufficiency; Prolapse
• Other Study ID Numbers: 69HCL16_0115; IDRCB (Registry Identifier: 2022-A02601-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No