Back to resultsEffectiveness 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)
Primary Purpose
Cardiovascular Diseases
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NeoChord beating heart mitral valve implantation
Control
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Heart Valve Diseases, Heart failure, Heart diseases, Mitral valve insufficiency
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:
- 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
Sites / Locations
- Hôpital Louis Pradel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
NeoChord DS1000 Artificial Chordae Delivery System
Control
Arm Description
Subjects randomized to the experimental group will undergo the NeoChord implantation
traditional mitral valve repair performed under cardiac arrest
Outcomes
Primary Outcome Measures
Combined incidence of Death from any cause, redo surgery for valve dysfunction, and moderate-severe (3+) or severe (4+) mitral regurgitation
Secondary Outcome Measures
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
Overall survival
Mitral valve reoperation free survival
mitral regurgitation > 2+
Freedom from rehospitalization for heart failure
Change in functional evaluation (NYHA)
Change in functional evaluation (6 minute walk test )
Change in quality of life score
by using the EQ-5D questionnaire ( European Quality of Life-5 Dimensions) instrument
Number of device success
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02829749
Brief Title
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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Because of dynamics in the field of minimal invasive mitral repair and the development of newer devices
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
Heart Valve Diseases, Heart failure, Heart diseases, Mitral valve insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NeoChord DS1000 Artificial Chordae Delivery System
Arm Type
Experimental
Arm Description
Subjects randomized to the experimental group will undergo the NeoChord implantation
Arm Title
Control
Arm Type
Other
Arm Description
traditional mitral valve repair performed under cardiac arrest
Intervention Type
Device
Intervention Name(s)
NeoChord beating heart mitral valve implantation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
traditional mitral valve repair performed under cardiac arrest
Primary Outcome Measure Information:
Title
Combined incidence of Death from any cause, redo surgery for valve dysfunction, and moderate-severe (3+) or severe (4+) mitral regurgitation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of patients with any major adverse events
Description
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
Time Frame
30 days
Title
Overall survival
Time Frame
12 months
Title
Mitral valve reoperation free survival
Time Frame
12 months
Title
mitral regurgitation > 2+
Time Frame
12 months
Title
Freedom from rehospitalization for heart failure
Time Frame
12 months
Title
Change in functional evaluation (NYHA)
Time Frame
12 months
Title
Change in functional evaluation (6 minute walk test )
Time Frame
12 months
Title
Change in quality of life score
Description
by using the EQ-5D questionnaire ( European Quality of Life-5 Dimensions) instrument
Time Frame
12 months
Title
Number of device success
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François OBADIA, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Louis Pradel
City
Bron
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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