An interventional study of NeoChord beating heart mitral valve implantation and Control in Cardiovascular Diseases, sponsored by Hospices Civils de Lyon. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
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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Class I indication for MV Surgery according to ESC/EACTS and AHA/ACC guidelines:
Exclusion Criteria:
Subjects randomized to the experimental group will undergo the NeoChord implantation
Device: NeoChord beating heart mitral valve implantation
traditional mitral valve repair performed under cardiac arrest
Procedure: Control
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.
traditional mitral valve repair performed under cardiac arrest
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
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
Time frame: 30 days
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
by using the EQ-5D questionnaire ( European Quality of Life-5 Dimensions) instrument
Time frame: 12 months
Number of device success
Time frame: 30 days
Plan to share: No
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This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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