Epicardial Mitral Repair Trial - ENRAPT-MR

Study Overview
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Brief Summary
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Mitral Touch System This device is designed to epicardially reshape the mitral valve annulus without the need for cardiopulmonary bypass (CPB) and open heart access (atriotomy), in patients with left ventricular dilation and ischemic or functional MR (mitral regurgitation (MR)).

Detailed Description
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Mitre Medical has developed an epicardial mitral annuloplasty device that can be implanted concomitant during planned coronary artery bypass surgery to help treat the MR patients. The Mitral Touch is designed to restore the S-L dimension and has the advantage of being placed without stopping the heart and placing the patient on a bypass pump.

Official Title
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ENRAPT-MR Trial: Epicardial Mitral Repair

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: Mitral Touch Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has moderate (2+), moderate-to-severe (3+) or severe (4+) ischemic or functional Mitral regurgitation per 2D or 3D echocardiography, symptomatic or asymptomatic Patient is 18 years of age or older Patient is willing and able to sign informed consent form Exclusion Criteria: History of endocarditis or current endocarditis Structural abnormalities of the leaflets and papillary muscles* Dysfunctional chordae* Any prior cardiac surgery including but not limited to CABG, Mitral Valve repair surgery, mechanical prosthetic Valve, or ventricular assist device, prior sternotomy* Ejection fraction <25% New York Hheart Association (NYHA) class IV MV diameters > 7cm Myxomatous Mitral regurgitation Renal insufficiency (eGFR &lt; 30 ml/min) Severely calcified (posterior) Mitral Valve annulus Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable) Any coronary artery calcification at site of placement as determined by angiogram. Abnormal cardiac anatomy discovered prior to surgery or during procedure. Pericardial adhesions NOTE: Patients with prior or concurrent mitral chordae repair (example: PTFE or Neochord) are potential candidates for the MitralTouch

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: Registry
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment with the Mitral Touch Implant for Epicardial Annuloplasty. | Device: Mitral Touch Implant<br>* The study population for this study will be comprised of patients who are to undergo cardiac surgery with a sternotomy (e.g. CABG) and who present moderate to severe ischemic or functional MR. In order to be considered eligible for the study, each patient must meet the conditions listed in the inclusion and none of the exclusion criteria.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - 30 - Day Major Adverse Event Rate | 30 - Day Major Adverse Event Rate All-cause mortality Stroke Life-threatening bleeding (MVARC scale) Major vascular complications Major cardiac structural complications Stage 2 or 3 acute kidney injury (includes new dialysis) Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for >48 h Emergency surgery or re-intervention related to the device or access procedure | 30-Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success - MR Reduction | MR assessment of MR Grade by TTE compared to baseline | 30-Days, 6 Months, 12 Months | 
| Technical Success - Coaptation Length Increase | An increase of coaptation length compared to baseline | 30-Days, 6 Months, 12 Months | 
| Technical Success - Septa-Lateral Reduction | Target of 15%-30% Reduction when compared to baseline | Implantation, 6 Months, 12 Months | 
| Technical Success - Improvement in NYHA Classification | Reduction in NYHA Classification compared to baseline | 6 & 12 Months |