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

Cardiovascular Diseases Clinical Trial

— MITRACHORD  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02829749
• Other study ID #: 69HCL16_0115
• Secondary ID: IDRCB
• Status: Withdrawn
• Phase: N/A
• Start date: June 2020
• Est. completion date: October 2022

Study information

• Verified date: January 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Mitral Valve Insufficiency
• Prolapse

Intervention

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.

Procedure:
• Control
traditional mitral valve repair performed under cardiac arrest

Locations

Country	Name	City	State
France	Hôpital Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined incidence of Death from any cause, redo surgery for valve dysfunction, and moderate-severe (3+) or severe (4+) mitral regurgitation		1 year
Secondary	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
Secondary	Overall survival		12 months
Secondary	Mitral valve reoperation free survival		12 months
Secondary	mitral regurgitation > 2+		12 months
Secondary	Freedom from rehospitalization for heart failure		12 months
Secondary	Change in functional evaluation (NYHA)		12 months
Secondary	Change in functional evaluation (6 minute walk test )		12 months
Secondary	Change in quality of life score	by using the EQ-5D questionnaire ( European Quality of Life-5 Dimensions) instrument	12 months
Secondary	Number of device success		30 days