ChordArt System for Mitral Regurgitation

Study Overview
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Brief Summary
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The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach. The implant is designed to allow transfemoral antegrade implantation.

Detailed Description
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ChordArt utilizes a minimally invasive catheter based approach by which multiple artificial chordae are precisely positioned into the papillary muscle and then secured to the pathological leaflet.

Official Title
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ChordArt System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail

Conditions
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Mitral Valve Repair, Mitral Regurgitation, Mitral Valve Insufficiency

Intervention / Treatment
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* Device: ChordArt System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Mitral Regurgitation due to degenerative mitral leaflet prolapse or flail Left Ventricular Ejection Fraction >20% New York Heart Association functional class II to IV Able and willing to give informed consent and follow protocol procedures. Exclusion Criteria: Life expectancy <1 year Hemodynamic instability Severe untreated ischemic disease Pulmonary Hypertension Any prior mitral valve surgery or transcatheter mitral valve procedure Stroke or transient ischemic event within 30 days before randomization Patient is pregnant (urine human chorionic gonadotropin (HCG) test result positive), planning to be pregnant or lactating. Renal insufficiency Acute anemia Chronic obstructive pulmonary disease Severe right ventricular dysfunction Hepatic insufficiency Patient is participating in other investigational studies

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm, multi-center, prospective, non-randomized study. The study is conducted in accordance with the guidelines of the Mitral Valve Academic Research Consortium (MVARC) regarding study design and endpoint definition as well as International Standards Organization 5840-3.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm<br>The ChordArt System is intended for chordal replacement in patients with mitral valve insufficiency due to leaflet prolapse or flail delivered through a catheter based technology for mitral chordal replacement via a small incision in the thorax. | Device: ChordArt System<br>* The ChordArt System is intended for chordal replacement in mitral valve insufficiency due to leaflet prolapse or flail. One or more ChordArt System may be utilized within the same intervention for optimal mitral valve treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | The frequency of all-cause mortality | At 30 days from implant procedure | 
| Major adverse events | The frequency of pre-determined major adverse events | At 30 days from implant procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | The technical success will be measured by the absence of procedural mortality, successful access, delivery of the ChordArt implant & retrieval of the ChordArt delivery system as well as successful ChordArt deployment, positioning and freedom from emergency surgery or re-intervention related to the device or access procedure. | End of Implantation Procedure | 
| Device Performance | The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography. | At 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degenerative Mitral Leaflet Prolapse, Heart Disease, Minimally Invasive