CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation

Study Overview
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Brief Summary
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The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines.

Official Title
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The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System® in Reducing Functional Mitral Regurgitation (FMR) Associated With Heart Failure

Conditions
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Mitral Valve Insufficiency, Heart Failure

Intervention / Treatment
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* Device: CARILLON Mitral Contour System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of dilated ischemic or non-ischemic cardiomyopathy Functional Mitral Regurgitation: 2+ (Moderate), 3+ (Moderate/Severe), or 4+ (Severe) New York Heart Association (NYHA) II, III, or IV Six Minute Walk distance of at least 150 meters and no farther than 450 meters Left Ventricular Ejection Fraction ≤ 50 % LV end diastolic dimension (LVEDD) >55mm or LVEDD/Body Surface Area (BSA) > 3.0cm/m2 Stable heart failure medication regimen for at least three (3) months prior to index procedure Exclusion Criteria: Hospitalization in past three (3) months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina Hospitalization in the past 30 days for coronary angioplasty or stent placement Subjects expected to require any cardiac surgery within one (1) year Subjects expected to require any percutaneous coronary intervention within 30 days of enrollment Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV), or anticipated need for CRT within twelve (12) months Presence of a coronary artery stent under the CS / GCV in the implant target zone Presence of left atrial appendage (LAA) clot. Presence of primary renal dysfunction or significantly compromised renal function as reflected by a serum creatinine > 2.2 mg/dL OR eGFR < 30 ml/min Inability to undertake a six-minute walk test due to physical restrictions/limitations Chronic severe pathology limiting survival to less than 12-months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Interventional Model Description: With crossover for sham procedure patients who are eligible at time of 12 month follow up.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Implantation of the CARILLON Mitral Contour System | Device: CARILLON Mitral Contour System<br>* Percutaneous mitral valve repair<br>* Other names: CARILLON XE2;|
| No Intervention: Control Group<br>Optimized stable medical therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in regurgitant volume associated with the CARILLON device relative to the Control population |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document the difference in the rate of major adverse events between Treatment (CARILLON) and Control groups |  | 30 days and 12 months | 
| Assess rate of heart failure hospitalizations between Treatment (CARILLON) and Control groups |  | 12 months | 
| Assess the change in six-minute walk distance between Treatment (CARILLON) and Control groups |  | 12 Months | 
| Assess the change in left ventricular volumes between Treatment (CARILLON) and Control groups |  | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary mitral regurgitation, Functional mitral regurgitation, Percutaneous mitral repair