Epicardial Mitral Touch System for Mitral Insufficiency

Study Overview
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Brief Summary
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To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.

Detailed Description
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The Mitral Touch Systems is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.

Official Title
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ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency

Conditions
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Ischemic Mitral Regurgitation, Functional Mitral Regurgitation

Intervention / Treatment
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* Device: Implant an epicardial device to reshape the mitral valve annulus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate or greater (2+) ischemic Functional Mitral regurgitation by 2D echocardiography using an integrative method Patient is scheduled for cardiac surgery (e.g. CABG including patients on the waiting list for Heart Transplantation) Patient is 22 years of age or older Patient is willing and able to sign Informed Consent Form Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States Exclusion Criteria: Any evidence of structural (chordal or leaflet) mitral valve disease Inability to derive ERO, LVESVI or LVEDVI by TTE Prior surgical or percutaneous mitral valve intervention Contraindication to cardiopulmonary bypass (CPB) Clinical signs of cardiogenic shock Treatment with chronic intravenous inotropic therapy Severe, irreversible pulmonary hypertension in the judgement of the investigator ST segment elevation requiring intervention within 7 days prior to randomization Congenital heart disease (except PFO or ASD) Evidence of cirrhosis or hepatic synthetic failure Renal insufficiency (eGFR < 30 ml/min) History of endocarditis or current endocarditis Ejection fraction <25% NY heart class IV MV diameters > 7cm Any coronary artery calcification at site of placement as determined by angiogram Myxomatous mitral regurgitation Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable) Abnormal cardiac anatomy discovered prior to surgery or during procedure Pericardial adhesions Insufficient clinical signature reduction of mitral regurgitation during device sizing and placement. (No device remains, patient moved to only 30-Day follow-up.)

Ages Eligible for Study
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Minimum Age: 22 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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, single arm, un-blinded, multi-center early feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Implantation<br>To epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy) using an epicardial implant. | Device: Implant an epicardial device to reshape the mitral valve annulus<br>* The implant is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Freedom from Major Adverse Events | Freedom from Major Adverse Events such as death, stroke, Increase of NYHA >1, Re-Hospitalization or reoperation of the Mitral Valve | Procedure through 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Technical Feasibility to implant the Mitral Touch Device | Septal lateral diameter reduction of the mitral valve at implantation, Reduction in MR Grade by at least 1 grade from baseline | Procedure | 
| Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device | Implantation of the Mitral Touch Device without Serious Adverse Events | procedure |