An interventional study of Carillon Mitral Contour System in Mitral Valve Insufficiency and Heart Failure, sponsored by Cardiac Dimensions Pty Ltd. Completed at 31 sites in 8 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-08-05.
Sponsored by Cardiac Dimensions Pty Ltd · Not applicable, Interventional, and Treatment
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.
The American Heart Association (AHA) estimates that there are more than 22 million people worldwide with heart failure. Functional mitral regurgitation, defined as the leakage of the mitral valve caused by global or regional changes in left ventricular geometry as well as mitral annular dilation, occurs as a consequence of heart failure. Cardiac Dimensions has developed proprietary technology designed to address functional mitral regurgitation in a minimally invasive manner.
Cardiac Dimensions plans to conduct a clinical trial of the Carillon Mitral Contour System in study subjects with functional mitral regurgitation. This study is a prospective, randomized parallel-group, double-blind, multi-center clinical trial designed to examine the safety and efficacy of the Carillon Mitral Contour System in study subjects with functional mitral regurgitation. The study will consent up to 180 subjects in order to randomize up to 120 subjects at 25 investigational sites in Europe and Australia/New Zealand. Subjects will be randomized into one of two study groups using a 3:1 (Treatment group : Control group) ratio.
Study subjects who are eligible for this clinical study and have consented to participating in the study will undergo multiple assessments prior to randomization to evaluate the eligibility (inclusion/exclusion) criteria. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Treatment or Control).
Study subjects randomized to the Treatment group will undergo a venous angiogram 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 Carillon implant procedure begins. With the distal aspect of the device anchored, incremental tension will be applied to plicate the peri-annular tissue. A transesophageal or transthoracic echocardiogram will be obtained during the procedure to evaluate the effect on functional mitral regurgitation and to evaluate left ventricular function. After the proximal anchor of the implant is locked in place, safety (including assessment of coronary arterial flow) and efficacy will be reconfirmed prior to releasing the Carillon implant from the delivery system.
Subjects randomized to the Control group will experience an index procedure similar to the Treatment group, however, without device placement. To ensure that subjects randomized to the Control group will not be able to deduce the treatment assignment based on the type of intervention or time associated with the procedure, minimal interventional procedures, such as femoral arterial pressure monitoring and a jugular venous drip. If a recent (within the last 3 months for ischemic cardiomyopathy or 12 months for non-ischemic cardiomyopathy) coronary angiogram is available, this assessment may be precluded.
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), and twelve (12) months post-implant, to assess long-term safety, and functional and clinical status. (Reference Section 3.8-Study Follow-up Evaluations)
This study will provide for an independent Clinical Events Committee (CEC) and an independent Data Safety Monitoring Board (DSMB). The CEC will be responsible for adjudicating complications reported during the study that are related to study endpoints (objectives), the procedure or the device. The DSMB will review the safety data against the established criteria and in the context of other safety data accumulated to date and the continued validity of the study.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 163 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Cardiac Dimensions Pty Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Implantation of the Carillon Mitral Contour System
Device: Carillon Mitral Contour System
Optimized stable medical therapy
Percutaneous mitral valve repair
Change in Baseline Regurgitant Volume Associated With the Carillon Device Relative to the Control Population at 12 Months
The primary echocardiographic index and primary endpoint of the REDUCE FMR study was Regurgitant Volume (RV) in the ITT population (N=120). RV was analyzed for the ITT patient population calculated as the mean change per randomization group among subjects with evaluable data. Between group comparisons were performed using the Students' t-test.
Time frame: Baseline and 12 months
Difference in the Rate of Major Adverse Events Between Treatment (Carillon) and Control Groups
Cumulative number of events for Death, Myocardial Infarction, Cardiac Perforation, Device embolization, and surgical or percutaneous intervention related to device.
Time frame: Baseline and 12 months
Rate of Heart Failure Hospitalizations Between Treatment (Carillon) and Control Groups
A diagnosis of acute decompensated heart failure hospitalization (ADHF) requires an in-hospital stay that includes at least one calendar date change and requires intravenous or mechanical heart failure treatment. The length of hospital stay will be calculated from admission to discharge to home or other disposition. The diagnosis of ADHF will be based on: * Symptoms of worsening heart failure such as increased shortness of breath, orthopnea, paroxysmal nocturnal dyspnea, fatigue, decreased exercise tolerance or history of weight gain; * Physical examination evidence such as neck vein distention, the presence of a third heart sound, bilateral pulmonary rales, worsening ascites or pedal edema, hypotension or signs of worsening end-organ perfusion; and/or * Laboratory evidence, which may include pulmonary congestion on chest x-ray, elevated natriuretic peptide level, worsening oxygenation or respiratory acidosis.
Time frame: Baseline and 12 months
Change in Six-minute Walk Distance Between Treatment (Carillon) and Control Groups
Subjects had 6-MWT conducted at baseline and each follow-up visit. The subject walked as far as they could within a 6-minute period. They were allowed to rest. The distance (in whole meters) was captured at each visit.
Time frame: Baseline and 12 Months
Change in Left Ventricular Volumes Between Treatment (Carillon) and Control Groups
The volume of the left ventricle will be measured by a blinded echosonographer ajdn submitted to the core lab for blinded analysis. The ventricle will be measured as systole and diastole.
Time frame: Baseline and 12 Months
163 subjects consented to randomize 120. 28 Screen Failed prior to procedure 15 Excluded at the procedure due to angiographic results
| Milestone | Treatment Group | Control Group |
|---|---|---|
| Started | 87 | 33 |
| Completed | 70 | 24 |
| Not completed | 17 | 9 |
The primary echocardiographic index and primary endpoint of the REDUCE FMR study was Regurgitant Volume (RV) in the ITT population (N=120). RV was analyzed for the ITT patient population calculated as the mean change per randomization group among subjects with evaluable data. Between group comparisons were performed using the Students' t-test.
| ml/beat | Treatment Group | Control Group |
|---|---|---|
| Change in Baseline Regurgitant Volume Associated With the Carillon Device Relative to the Control Population at 12 Months | -7.07 (-11.68 to -2.46) | 3.32 (-5.98 to 12.62) |
Cumulative number of events for Death, Myocardial Infarction, Cardiac Perforation, Device embolization, and surgical or percutaneous intervention related to device.
| Mitral Regurgitant Volume (mL) | Treatment Group | Control Group |
|---|---|---|
| Difference in the Rate of Major Adverse Events Between Treatment (Carillon) and Control Groups | -7.07 (-11.68 to -2.46) | 3.32 (-5.98 to 12.62) |
A diagnosis of acute decompensated heart failure hospitalization (ADHF) requires an in-hospital stay that includes at least one calendar date change and requires intravenous or mechanical heart failure treatment. The length of hospital stay will be calculated from admission to discharge to home or other disposition. The diagnosis of ADHF will be based on: * Symptoms of worsening heart failure such as increased shortness of breath, orthopnea, paroxysmal nocturnal dyspnea, fatigue, decreased exercise tolerance or history of weight gain; * Physical examination evidence such as neck vein distention, the presence of a third heart sound, bilateral pulmonary rales, worsening ascites or pedal edema, hypotension or signs of worsening end-organ perfusion; and/or * Laboratory evidence, which may include pulmonary congestion on chest x-ray, elevated natriuretic peptide level, worsening oxygenation or respiratory acidosis.
| Rate of HFH per patient-year | Treatment Group | Control Group |
|---|---|---|
| Rate of Heart Failure Hospitalizations Between Treatment (Carillon) and Control Groups | 0.57 (0.41 to 0.72) | 0.73 (0.44 to 1.03) |
Subjects had 6-MWT conducted at baseline and each follow-up visit. The subject walked as far as they could within a 6-minute period. They were allowed to rest. The distance (in whole meters) was captured at each visit.
| Meters | Treatment Group | Control Group |
|---|---|---|
| Change in Six-minute Walk Distance Between Treatment (Carillon) and Control Groups | 32.0 (-10.0 to 70) | 17.5 (-20.0 to 46.5) |
The volume of the left ventricle will be measured by a blinded echosonographer ajdn submitted to the core lab for blinded analysis. The ventricle will be measured as systole and diastole.
| mL | Treatment Group | Control Group |
|---|---|---|
| LVEDV | -10.42 (-18.18 to -2.37) | 6.54 (-5.14 to 18.22) |
| LVESV | -6.19 (-12.78 to 0.39) | 6.1 (-1.42 to 13.63) |
Collected over Adverse Event Data was collected from the time of consent to 12-month post randomization.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | 11/87 (12.6%) | 46/87 (52.9%) | 0/87 (0%) |
| Control Group | 5/33 (15.2%) | 19/33 (57.6%) | 0/33 (0%) |
| Event | Treatment Group | Control Group |
|---|---|---|
| Heart Failure ExacerbationCardiac disorders | 24/87 | 11/33 |
| Acute Coronary SyndromesCardiac disorders | 2/87 | 2/33 |
| EndocarditisCardiac disorders | 0/87 | 2/33 |
| InfectionInfections and infestations | 4/87 | 2/33 |
| Arrhythmia - Atrial FibrillationCardiac disorders | 4/87 | 1/33 |
| GastrointestinalGastrointestinal disorders | 4/87 | 1/33 |
| Intracerebral BleedingVascular disorders | 0/87 | 1/33 |
| Worsening of Mitral RegurgitationCardiac disorders | 2/87 | 0/33 |
| Arrhythmia - Ventricular FibrillationCardiac disorders | 1/87 | 0/33 |
| Arrhythmia - Ventricular TachycardiaCardiac disorders | 1/87 | 0/33 |
| Age, Continuous(years) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 70.1 ± 9.7 | 69.1 ± 8.9 | 69.8 ± 9.5 |
| Sex: Female, Male(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Female | 24 | 9 | 33 |
| Male | 63 | 24 | 87 |
| Race and Ethnicity Not Collected(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| NYHA(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| NYHA II Mild symptoms | 39 | 16 | 55 |
| NYHA III Marked limitation | 46 | 17 | 63 |
| NYHA IV Severe limitations | 2 | 0 | 2 |
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Cardiac Dimensions Pty Ltd