Trial Outcomes & Findings for Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation (NCT NCT02325830)

Last Updated: 2024-08-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

163 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2024-08-05

Participant Flow

163 subjects consented to randomize 120. 28 Screen Failed prior to procedure 15 Excluded at the procedure due to angiographic results

Participant milestones

Participant milestones
Measure	Treatment Group CARILLON Mitral Contour System: Percutaneous mitral valve repair	Control Group Optimized stable medical therapy
Overall Study STARTED	87	33
Overall Study COMPLETED	70	24
Overall Study NOT COMPLETED	17	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=87 Participants CARILLON Mitral Contour System: Percutaneous mitral valve repair	Control Group n=33 Participants Optimized stable medical therapy	Total n=120 Participants Total of all reporting groups
Age, Continuous	70.1 years STANDARD_DEVIATION 9.7 • n=87 Participants	69.1 years STANDARD_DEVIATION 8.9 • n=33 Participants	69.8 years STANDARD_DEVIATION 9.5 • n=120 Participants
Sex: Female, Male Female	24 Participants n=87 Participants	9 Participants n=33 Participants	33 Participants n=120 Participants
Sex: Female, Male Male	63 Participants n=87 Participants	24 Participants n=33 Participants	87 Participants n=120 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
NYHA NYHA II Mild symptoms	39 Participants n=87 Participants	16 Participants n=33 Participants	55 Participants n=120 Participants
NYHA NYHA III Marked limitation	46 Participants n=87 Participants	17 Participants n=33 Participants	63 Participants n=120 Participants
NYHA NYHA IV Severe limitations	2 Participants n=87 Participants	0 Participants n=33 Participants	2 Participants n=120 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: Image quality from sites reduced ultimate number of images able to be analyze by central review committee for RV values.

Outcome measures

Outcome measures
Measure	Treatment Group n=55 Participants Implantation of the Carillon Mitral Contour System Carillon Mitral Contour System: Percutaneous mitral valve repair	Control Group n=13 Participants Optimized stable medical therapy
Change in Baseline Regurgitant Volume Associated With the Carillon Device Relative to the Control Population at 12 Months	-7.07 ml/beat Interval -11.68 to -2.46	3.32 ml/beat Interval -5.98 to 12.62

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: 120 randomized subjects, regardless of follow-up period.

Cumulative number of events for Death, Myocardial Infarction, Cardiac Perforation, Device embolization, and surgical or percutaneous intervention related to device.

Outcome measures

Outcome measures
Measure	Treatment Group n=87 Participants Implantation of the Carillon Mitral Contour System Carillon Mitral Contour System: Percutaneous mitral valve repair	Control Group n=33 Participants Optimized stable medical therapy
Difference in the Rate of Major Adverse Events Between Treatment (Carillon) and Control Groups	-7.07 Mitral Regurgitant Volume (mL) Interval -11.68 to -2.46	3.32 Mitral Regurgitant Volume (mL) Interval -5.98 to 12.62

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Randomized subjects, per treatment arm

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=87 Participants Implantation of the Carillon Mitral Contour System Carillon Mitral Contour System: Percutaneous mitral valve repair	Control Group n=33 Participants Optimized stable medical therapy
Rate of Heart Failure Hospitalizations Between Treatment (Carillon) and Control Groups	0.57 Rate of HFH per patient-year Interval 0.41 to 0.72	0.73 Rate of HFH per patient-year Interval 0.44 to 1.03

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Randomized subjects

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=87 Participants Implantation of the Carillon Mitral Contour System Carillon Mitral Contour System: Percutaneous mitral valve repair	Control Group n=33 Participants Optimized stable medical therapy
Change in Six-minute Walk Distance Between Treatment (Carillon) and Control Groups	32.0 Meters Interval -10.0 to 70.0	17.5 Meters Interval -20.0 to 46.5

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Randomized population with paired images from baseline to 12-month only.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=47 Participants Implantation of the Carillon Mitral Contour System Carillon Mitral Contour System: Percutaneous mitral valve repair	Control Group n=16 Participants Optimized stable medical therapy
Change in Left Ventricular Volumes Between Treatment (Carillon) and Control Groups LVEDV	-10.42 mL Interval -18.18 to -2.37	6.54 mL Interval -5.14 to 18.22
Change in Left Ventricular Volumes Between Treatment (Carillon) and Control Groups LVESV	-6.19 mL Interval -12.78 to 0.39	6.1 mL Interval -1.42 to 13.63

Adverse Events

Treatment Group

Serious events: 46 serious events

Other events: 0 other events

Deaths: 11 deaths

Control Group

Serious events: 19 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group n=87 participants at risk Implantation of the CARILLON Mitral Contour System CARILLON Mitral Contour System: Percutaneous mitral valve repair	Control Group n=33 participants at risk Optimized stable medical therapy
Cardiac disorders Acute Coronary Syndromes	2.3% 2/87 • Number of events 2 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	6.1% 2/33 • Number of events 2 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Cardiac disorders Arrhythmia - Atrial Fibrillation	4.6% 4/87 • Number of events 4 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	3.0% 1/33 • Number of events 1 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Cardiac disorders Arrhythmia - Ventricular Fibrillation	1.1% 1/87 • Number of events 1 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	0.00% 0/33 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Cardiac disorders Arrhythmia - Ventricular Tachycardia	1.1% 1/87 • Number of events 1 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	0.00% 0/33 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Cardiac disorders Coronary Spasm	1.1% 1/87 • Number of events 1 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	0.00% 0/33 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Cardiac disorders ICD Device Shock	1.1% 1/87 • Number of events 1 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	0.00% 0/33 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Cardiac disorders Heart Failure Exacerbation	27.6% 24/87 • Number of events 24 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	33.3% 11/33 • Number of events 11 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Cardiac disorders Endocarditis	0.00% 0/87 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	6.1% 2/33 • Number of events 2 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Cardiac disorders Sick Sinus Syndrome	1.1% 1/87 • Number of events 1 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	0.00% 0/33 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Cardiac disorders Worsening of Mitral Regurgitation	2.3% 2/87 • Number of events 2 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	0.00% 0/33 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Gastrointestinal disorders Gastrointestinal	4.6% 4/87 • Number of events 4 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	3.0% 1/33 • Number of events 1 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Infections and infestations Infection	4.6% 4/87 • Number of events 4 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	6.1% 2/33 • Number of events 2 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Vascular disorders Intracerebral Bleeding	0.00% 0/87 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	3.0% 1/33 • Number of events 1 • Adverse Event Data was collected from the time of consent to 12-month post randomization.
Vascular disorders Lacunar Stroke	1.1% 1/87 • Number of events 1 • Adverse Event Data was collected from the time of consent to 12-month post randomization.	0.00% 0/33 • Adverse Event Data was collected from the time of consent to 12-month post randomization.

Other adverse events

Adverse event data not reported

Additional Information

Vice President of Clinica Affairs

Cardiac Dimensions

Phone: 425-605-5922

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60