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

Not Applicable

Withdrawn

• Conditions: Cardiovascular Diseases
• Interventions: Procedure: Control; Device: NeoChord beating heart mitral valve implantation

• Registration Number: NCT02829749
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13
• Study Start: 2020-06
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	traditional mitral valve repair performed under cardiac arrest
NeoChord DS1000 Artificial Chordae Delivery System	NeoChord beating heart mitral valve implantation	Subjects randomized to the experimental group will undergo the NeoChord implantation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall survival	12 months
mitral regurgitation > 2+	12 months
Mitral valve reoperation free survival	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
Freedom from rehospitalization for heart failure	12 months
Change in functional evaluation (6 minute walk test )	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 functional evaluation (NYHA)	12 months

Trial Locations

Locations (1)

Hôpital Louis Pradel; 🇫🇷 Bron, France