N/A
N=120
Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation
Mitral Valve Insufficiency · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02325830 ↗Enrolled (actual)
120
Serious AEs
54.2%
Results posted
Aug 2024
Primary outcome: Primary: Change in Baseline Regurgitant Volume Associated With the Carillon Device Relative to the Control Population at 12 Months — -7.07; 3.32 ml/beat
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Carillon Mitral Contour System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cardiac Dimensions Pty Ltd
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baseline Regurgitant Volume Associated With the Carillon Device Relative to the Control Population at 12 Months |
-7.07; 3.32 | — |
| PRIMARY Difference in the Rate of Major Adverse Events Between Treatment (Carillon) and Control Groups |
-7.07; 3.32 | — |
| SECONDARY Rate of Heart Failure Hospitalizations Between Treatment (Carillon) and Control Groups |
0.57; 0.73 | — |
| SECONDARY Change in Six-minute Walk Distance Between Treatment (Carillon) and Control Groups |
32.0; 17.5 | — |
| SECONDARY Change in Left Ventricular Volumes Between Treatment (Carillon) and Control Groups |
-10.42; 6.54; -6.19; 6.1 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02325830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.