Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

Study Overview
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Brief Summary
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The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.

Detailed Description
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This study is an observational, single-arm, multicenter post-market registry. Both prospective and retrospective enrollment will be allowed. No additional invasive or burdensome examinations outside those routinely required for the standard mitral valve repair procedure will be requested.

Official Title
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The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

Conditions
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Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency, Mitral Valve Prolapse, Heart Valve Diseases

Intervention / Treatment
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* Device: NeoChord Artificial Chordae Delivery System, Model DS1000


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation Study procedure completed after 31 December 2016 Exclusion Criteria: Heavily calcified valves Valvular retraction with severely reduced mobility Active bacterial endocarditis Complex mechanism of MR (leaflet perforation, etc.) Significant tethering of leaflets Inflammatory valve disease

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NeoChord Artificial Chordae Delivery System, Model DS1000|The intended use of the device is for the placement of artificial chordae when the natural chordae tendinae have become elongated or ruptured due to degenerative valve disease.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Mitral Regurgitation Following the Index Procedure | Level of mitral regurgitation per echocardiography | Completion of Index Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Mitral Regurgitation at 3-6 Months | Level of mitral regurgitation per echocardiography | 3-6 Months | 
| Level of Mitral Regurgitation at 1 Year | Level of mitral regurgitation per echocardiography | 1 Year | 
| Level of Mitral Regurgitation at 2 Years | Level of mitral regurgitation per echocardiography | 2 Years | 
| Level of Mitral Regurgitation at 3 Years | Level of mitral regurgitation per echocardiography | 3 Years | 
| Level of Mitral Regurgitation at 4 Years | Level of mitral regurgitation per echocardiography | 4 Years | 
| Level of Mitral Regurgitation at 5 Years | Level of mitral regurgitation per echocardiography | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NeoChord, DS1000, Artificial Chordae, Mitral Valve Repair