CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation (REDUCE FMR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02325830 |
Recruitment Status :
Completed
First Posted : December 25, 2014
Last Update Posted : August 7, 2018
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Condition or disease | Intervention/treatment | Phase |
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Mitral Valve Insufficiency Heart Failure | Device: CARILLON Mitral Contour System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 163 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | With crossover for sham procedure patients who are eligible at time of 12 month follow up. |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System® in Reducing Functional Mitral Regurgitation (FMR) Associated With Heart Failure |
Actual Study Start Date : | March 2015 |
Actual Primary Completion Date : | July 2018 |
Actual Study Completion Date : | July 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment Group
Implantation of the CARILLON Mitral Contour System
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Device: CARILLON Mitral Contour System
Percutaneous mitral valve repair
Other Name: CARILLON XE2 |
No Intervention: Control Group
Optimized stable medical therapy
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- Change in regurgitant volume associated with the CARILLON device relative to the Control population [ Time Frame: 12 months ]
- Document the difference in the rate of major adverse events between Treatment (CARILLON) and Control groups [ Time Frame: 30 days and 12 months ]
- Assess rate of heart failure hospitalizations between Treatment (CARILLON) and Control groups [ Time Frame: 12 months ]
- Assess the change in six-minute walk distance between Treatment (CARILLON) and Control groups [ Time Frame: 12 Months ]
- Assess the change in left ventricular volumes between Treatment (CARILLON) and Control groups [ Time Frame: 12 Months ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325830

Principal Investigator: | Horst Sievert, MD | Cardio Vascular Center | |
Principal Investigator: | David Kaye, MD | The Alfred |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Cardiac Dimensions Pty Ltd |
ClinicalTrials.gov Identifier: | NCT02325830 |
Other Study ID Numbers: |
CVP 1627-01 |
First Posted: | December 25, 2014 Key Record Dates |
Last Update Posted: | August 7, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Functional mitral regurgitation Secondary mitral regurgitation Percutaneous mitral repair |
Heart Failure Mitral Valve Insufficiency Heart Diseases Cardiovascular Diseases Heart Valve Diseases |