Overview
The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).
Description
A total of 300 subjects will be randomized at up to 75 investigational sites in the United States, Canada, Europe and Australia. Subjects will be randomized into one of two study groups using a 1:1 (Intervention : Control) ratio.
Study subjects who are eligible for this clinical study will undergo a transthoracic echocardiographic examination prior to randomization to evaluate the inclusion criteria associated with the severity of mitral regurgitation. A coronary angiogram will be performed to evaluate the coronary artery anatomy and a venogram to assess the suitability of the coronary sinus/great cardiac vein (CS/GCV) for placement of the Carillon implant. If the subject meets the anatomic requirements for device placement, the subject will be randomized. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Intervention or Control).
Subjects randomized to the Intervention group will undergo the Carillon implant procedure.
Subjects randomized to the Control group will experience an index procedure similar to the Intervention group (without device placement) to ensure they will not be able to deduce the group assignment based on the type of intervention or time associated with the procedure.
After the study subjects are discharged, the subjects' primary care specialists (cardiologist/heart failure physician) and clinical investigation site staff will coordinate follow-up evaluations. Subjects will be evaluated at one (1), six (6), twelve (12), eighteen (18) and twenty-four (24) months post-randomization, to assess long-term safety, and functional and clinical status.
After the 24-month evaluation, all subjects will be unblinded. All Intervention and Control subjects will be followed with an abbreviated annual contact and echocardiogram for an additional three (3) years, for a total of five (5) years.
Eligibility
Inclusion Criteria:
- Diagnosis of ischemic or non-ischemic cardiomyopathy
- Symptomatic functional (secondary) mitral regurgitation of at least 1+ (Mild) severity Note: 4+ 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.
- NYHA Class II, III, or IV
- Six Minute Walk distance ≥ 150 meters and ≤ 450 meters
- Left Ventricular Ejection Fraction ≤ 50%
- LVEDD ≥ 60 mm and LVESD ≤ 75 mm
- Corrected BNP of ≥ 300 pg/ml, or corrected NT-proBNP ≥ 1200 pg/ml, or one or more heart failure hospitalizations within six months prior to consent
- Guideline directed heart failure medication regimen.
Exclusion Criteria:
- Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV)
- Class I indication for cardiac resynchronization therapy (CRT), or anticipated need for CRT within twelve (12) months
- Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
- Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture), as assessed by the 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
- Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
- Presence of left atrial appendage (LAA) clot or presence of LAA occluder
- Chronic, severe, medical conditions or pathology, other than heart failure, that will
prevent likely survival beyond twelve (12) months
- An entire list of eligibility is available in the clinical investigational plan