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CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation (REDUCE FMR)

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ClinicalTrials.gov Identifier: NCT02325830
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Menzies Institute for Medical Research
Information provided by (Responsible Party):
Cardiac Dimensions Pty Ltd

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Heart Failure Device: CARILLON Mitral Contour System Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group
Implantation of the CARILLON Mitral Contour System
 Device: CARILLON Mitral Contour System
Percutaneous mitral valve repair
Other Name: CARILLON XE2
No Intervention: Control Group
Optimized stable medical therapy


Outcome Measures
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Primary Outcome Measures :
  1. Change in regurgitant volume associated with the CARILLON device relative to the Control population [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Document the difference in the rate of major adverse events between Treatment (CARILLON) and Control groups [ Time Frame: 30 days and 12 months ]
  2. Assess rate of heart failure hospitalizations between Treatment (CARILLON) and Control groups [ Time Frame: 12 months ]
  3. Assess the change in six-minute walk distance between Treatment (CARILLON) and Control groups [ Time Frame: 12 Months ]
  4. Assess the change in left ventricular volumes between Treatment (CARILLON) and Control groups [ Time Frame: 12 Months ]

Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


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Sponsors and Collaborators
Cardiac Dimensions Pty Ltd
Menzies Institute for Medical Research
Investigators
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Principal Investigator: Horst Sievert, MD Cardio Vascular Center
Principal Investigator: David Kaye, MD The Alfred
More Information
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Additional Information:
Cardiac Dimensions - Current Clinical Studies  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cardiac Dimensions Pty Ltd
ClinicalTrials.gov Identifier: NCT02325830     History of Changes
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
Keywords provided by Cardiac Dimensions Pty Ltd:
Functional mitral regurgitation
Secondary mitral regurgitation
Percutaneous mitral repair
Additional relevant MeSH terms:
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Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases