Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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).
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
1. Diagnosis of ischemic or non-ischemic cardiomyopathy
2. 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.
3. NYHA Class II, III, or IV
4. Six Minute Walk distance ≥ 150 meters and ≤ 450 meters
5. Left Ventricular Ejection Fraction ≤ 50%
6. LVEDD ≥ 60 mm and LVESD ≤ 70 mm
7. 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
8. Guideline directed heart failure medication regimen.
Exclusion Criteria:
1. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein
(GCV)
2. Class I indication for cardiac resynchronization therapy (CRT), or anticipated need
for CRT within twelve (12) months
3. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty,
or leaflet repair device
4. 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
5. Severe tricuspid regurgitation associated with right ventricular dysfunction and
enlargement, as assessed by the Imaging Core Laboratory
6. Severe mitral annular calcification
7. Severe aortic stenosis
8. Expected to require any cardiac surgery, including surgery for coronary artery disease
(CAD) or valve disease within one (1) year
9. Presence of left atrial appendage (LAA) clot or presence of LAA occluder
10. 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