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)
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| ClinicalTrials.gov Identifier: NCT02829749 |
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Recruitment Status :
Not yet recruiting
First Posted : July 12, 2016
Last Update Posted : May 1, 2018
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Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases | Device: NeoChord beating heart mitral valve implantation Procedure: Control | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 194 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Estimated Study Start Date : | May 2018 |
| Estimated Primary Completion Date : | March 2021 |
| Estimated Study Completion Date : | March 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: NeoChord DS1000 Artificial Chordae Delivery System
Subjects randomized to the experimental group will undergo the NeoChord implantation
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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. |
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Control
traditional mitral valve repair performed under cardiac arrest
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Procedure: Control
traditional mitral valve repair performed under cardiac arrest |
Primary Outcome Measures :
- 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 Measures :
- Proportion of patients with any major adverse events [ Time Frame: 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
- Overall survival [ Time Frame: 12 months ]
- Mitral valve reoperation free survival [ Time Frame: 12 months ]
- mitral regurgitation > 2+ [ Time Frame: 12 months ]
- Freedom from rehospitalization for heart failure [ Time Frame: 12 months ]
- Change in functional evaluation (NYHA) [ Time Frame: 12 months ]
- Change in functional evaluation (6 minute walk test ) [ Time Frame: 12 months ]
- Change in quality of life score [ Time Frame: 12 months ]by using the EQ-5D questionnaire ( European Quality of Life-5 Dimensions) instrument
- Number of device success [ Time Frame: 30 days ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Severe primary mitral regurgitation (grade 3+ or 4+)
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829749
Contacts
| Contact: Jean-François OBADIA, MD | 4 72 35 72 47 ext +33 | jean-francois.obadia@chu-lyon.fr | |
| Contact: Nathan MEWTON, MD | 4 27 85 66 87 | nathan.mewton@chu-lyon.fr |
Locations
| France | |
| Hôpital Louis Pradel | Recruiting |
| Bron, France | |
| Contact: Jean-François Obadia, Pr | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Jean-François OBADIA, MD | Hospices Civils de Lyon |
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT02829749 History of Changes |
| Other Study ID Numbers: |
69HCL16_0115 |
| First Posted: | July 12, 2016 Key Record Dates |
| Last Update Posted: | May 1, 2018 |
| Last Verified: | February 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Hospices Civils de Lyon:
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Heart Valve Diseases Heart failure Heart diseases Mitral valve insufficiency |
Additional relevant MeSH terms:
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Cardiovascular Diseases Prolapse Mitral Valve Insufficiency |
Pathological Conditions, Anatomical Heart Valve Diseases Heart Diseases |