Clinical trial NCT02829749: 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
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Heart Valve Diseases
Heart failure
Heart diseases
Mitral valve insufficiency
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Combined incidence of Death from any cause, redo surgery for valve dysfunction, and moderate-severe (3+) or severe (4+) mitral regurgitation
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of patients with any major adverse events
timeFrame: 30 days
measure: Overall survival
timeFrame: 12 months
measure: Mitral valve reoperation free survival
timeFrame: 12 months
measure: mitral regurgitation > 2+
timeFrame: 12 months
measure: Freedom from rehospitalization for heart failure
timeFrame: 12 months
measure: Change in functional evaluation (NYHA)
timeFrame: 12 months
measure: Change in functional evaluation (6 minute walk test )
timeFrame: 12 months
measure: Change in quality of life score
timeFrame: 12 months
measure: Number of device success
timeFrame: 30 days
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-François OBADIA, MD
role: PRINCIPAL_INVESTIGATOR
References: