Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

Study Overview
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Brief Summary
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The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).

Official Title
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Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair

Conditions
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Mitral Valve Insufficiency

Intervention / Treatment
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* Device: NeoChord DS1000
* Device: Surgical Mitral Valve Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a candidate for mitral valve repair with cardiopulmonary bypass Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement Anatomic and general suitability Exclusion Criteria: Prior mitral valve surgery Concomitant cardiac procedures Other cardiac procedures within 3 months

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000 | Device: NeoChord DS1000<br>* Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000<br>|
| Active Comparator: Control Group<br>Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair | Device: Surgical Mitral Valve Repair<br>* Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group. |  | Post-operative Day (POD) 30 | 
| Proportion of subjects free of Grade II, III or IV mitral regurgitation, mitral valve replacement or mitral valve reintervention in the treatment group when compared to subjects in the control group. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degenerative, Mitral Regurgitation