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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Other Identifier | 2017-A01387-46 |
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Because of dynamics in the field of minimal invasive mitral repair and the development of newer devices
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeoChord DS1000 Artificial Chordae Delivery System | Experimental | Subjects randomized to the experimental group will undergo the NeoChord implantation |
|
| Control | Other | traditional mitral valve repair performed under cardiac arrest |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoChord beating heart mitral valve implantation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Combined incidence of Death from any cause, redo surgery for valve dysfunction, and moderate-severe (3+) or severe (4+) mitral regurgitation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Severe primary mitral regurgitation (grade 3+ or 4+)
Class I indication for MV Surgery according to ESC/EACTS and AHA/ACC guidelines:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-François OBADIA, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis Pradel | Bron | France |
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| Control | Procedure | traditional mitral valve repair performed under cardiac arrest |
|
| Overall survival | 12 months |
| Mitral valve reoperation free survival | 12 months |
| mitral regurgitation > 2+ | 12 months |
| Freedom from rehospitalization for heart failure | 12 months |
| Change in functional evaluation (NYHA) | 12 months |
| Change in functional evaluation (6 minute walk test ) | 12 months |
| Change in quality of life score | by using the EQ-5D questionnaire ( European Quality of Life-5 Dimensions) instrument | 12 months |
| Number of device success | 30 days |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006349 | Heart Valve Diseases |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D008944 | Mitral Valve Insufficiency |
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