EMPOWER Trial

• Diagnosis of ischemic or non-ischemic cardiomyopathy
• Symptomatic functional (secondary) mitral regurgitation of at least 1+(mild) severity
  • Note: 4+ (severe) can only be included if multidisciplinary site assessment (including a surgeon) determines that surgery is not necessary within the 1-year follow up period for this study.
  • Note: As assessed by Imaging Core Laboratory.
• NYHA II, III, or IVa
  • Note: Refer to Appendix D – NYHA Classification of Patients with Diseases of the Heart
• Six-Minute Walk distance ≥ 150 meters and ≤ 450 meters
• Left Ventricular Ejection Fraction ≤ 50%
  • Note: As assessed by Imaging Core Laboratory. Contrast echocardiography may be used only if the echocardiogram is difficult to assess.
• LVEDD ≥ 60 mm and LVESD ≤ 70 mm
  • Note: As assessed by Imaging Core Laboratory.
• Corrected BNP of > 300 pg/ml, or corrected NT-proBNP > 1200pg/ml, or one or more heart failure hospitalizations within six months prior to consent
  • Note: “Corrected” refers to a 4% reduction in BNP or NT-proBNP for every increase in 1 kg/m2 in BMI above the reference BMI of 20 kg/m2.
  • Note: See section 11.2 - Definitions for definition of Heart Failure Hospitalization. Heart failure hospitalization within 30 days prior to the enrollment period (consent, or between consent and index procedure) are excluded per exclusion #2.
• Guideline directed heart failure medication regimen
  • Note: See section 11.2 – Definitions and Appendix G - Guideline Directed Therapy for details.
• Age ≥ 18
• CARILLON implant can be sized and placed in accordance with the IFU
• The subject or the subject’s legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow up visits, and has provided written informed consent

Heart Failure

• Recipient of intravenous positive-inotrope infusion or intra-aortic balloon pump support within the past 30 days
• Heart failure hospitalization within the past 30 days
  • Note: See section 11.2 - Definitions for definition of heart failure hospitalization.
• Anticipated need of left ventricular assist device within twelve (12) months
• Class I indication for cardiac resynchronization therapy (CRT), or anticipated need for CRT within twelve (12) months
• Primary renal dysfunction or compromised renal function as reflected by an estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, as assessed by MDRD formula, or patients on dialysis
• Heart transplant candidate or prior orthotopic heart transplantation
• Unlikely to benefit from annular reduction therapy
  • Note: Obvious echocardiographic demonstration of enlarged coronary sinus so as to be unlikely to accommodate device, where annular dilatation is not the predominant pathology, immobile posterior leaflet, severe wall motion abnormality or other pathology that in opinion of the review committee would make the patient unlikely to benefit from annular reduction therapy.

 

Anatomical

• Presence of a mechanical or bio-prosthetic mitral valve, mitral valve annuloplasty or leaflet repair device
• Hypertrophic cardiomyopathy, infiltrative cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
• Echocardiographic documentation of non-compaction cardiomyopathy as assessed by the Imaging Core Laboratory
• Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV)
• Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease or full or partial chordal rupture), as assessed by Imaging Core Laboratory
• Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
• Severe mitral annular calcification
• Severe aortic stenosis
• Not a candidate for right internal jugular venous cannulation
• Cardiovascular Disease
• Hospitalization in past 30 days due to myocardial infarction, coronary artery bypass graft surgery or unstable angina
• Cerebral vascular event within the past 30 days
• Hospitalization in the past 30 days for coronary angioplasty or stent placement or ICD implant
• Pulmonary embolus or deep vein thrombosis within the past six (6) months
• Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or for valve disease, within one (1) year
  • Note: CAD is defined as unprotected left main stenosis greater than or equal to 50%, or stenosis greater than or equal to 70% in at least three (3) epicardial coronary arteries in the absence of prior bypass surgery.
• Expected to require any percutaneous coronary intervention within 30 days of the index procedure
• Hemodynamic instability defined as sustained systolic blood pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device
• Presence of left atrial appendage (LAA) clot, or presence of LAA occluder
  • Note: Subjects with a current/ongoing history of atrial fibrillation (documented within the last 12 months) must undergo a trans-esophageal echo (TEE) prior to the procedure to rule out LAA clot to minimize the risk of thrombo-embolism caused by the mitral annular plication. Subjects with current anticoagulants may not need TEE, at the investigator’s discretion.
  • Note: If an LAA clot is identified and treated, the subject can be evaluated for the study.

General

• Anemia defined as hemoglobin < 9.0 mg/dL
• Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
  • Note: Clinical studies requiring extended follow up for products that were investigational but have since become commercially available are not considered investigation trials.
• Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
• Active infections requiring current antibiotic therapy
• Chronic, severe medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months
• Female subjects pregnant or planning to become pregnant in the next five (5) years
• Subjects unable to perform the required study assessments (e.g., Six-Minute Walk Test)
• Any other medical condition that, in the judgment of the Investigator, makes the patient a poor candidate for this study
• Subjects belonging to a vulnerable population (see Section 11.2 -Definitions) per investigator’s judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or comply with the study procedures