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

August 3, 2018 updated by: Cardiac Dimensions Pty Ltd

The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System® in Reducing Functional Mitral Regurgitation (FMR) Associated With Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia
        • Prince Charles
    • New South Wales
      • St. Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Sydney, New South Wales, Australia
        • Royal Prince Alfred
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health
      • Prahran, Victoria, Australia, 3181
        • Alfred Health
  • Czechia
      • Olomouc, Czechia
        • Olomouc University Hospital
      • Prague, Czechia
        • Na Homolce Hospital
      • Prague, Czechia
        • Institut Klinicke a Experimentalni Mediciny (IKEM)
  • France
      • Caen, France, 14000
        • Hôpital Privé Saint-Martin
      • Montpellier, France
        • Clinique du Millénaire
      • Paris, France
        • European Hospital Georges Pompidou
      • Rouen, France
        • Hopital Charles Nicolle
      • Rouen, France, 76000
        • Clinique Saint-Hilaire
      • Toulouse, France, 31059
        • CHU Rangueil
    • Auvergne
      • Clermont Ferrand, Auvergne, France
        • Pôle Santé République
  • Germany
      • Berlin, Germany, 12203
        • Charite Universitatsmedizin Berlin
      • Bochum, Germany, 44791
        • Augusta Kranken-Anstalt GmbH
      • Frankfurt, Germany
        • Cardio Vascular Center Frankfurt
      • Frankfurt, Germany
        • Klinikum Frankfurt Höchst GmbH
      • Frankfurt am Main, Germany
        • University Hospital Frankfurt
      • Freiburg, Germany
        • Universitats-Herzzentrum Freiburg
      • Lübeck, Germany
        • Sana Kliniken Lübeck
      • Recklinghausen, Germany, 45661
        • Elisabeth Krankenhaus GmbH
    • North Rhine-Westphalia
      • Lüdenscheid, North Rhine-Westphalia, Germany, 58515
        • Märkische Kliniken GmbH, Klinikum Lüdenscheid
  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • Maastricht University Medical Centre
  • New Zealand
      • Grafton, New Zealand, 1030
        • Auckland City Hospital
  • Poland
      • Poznan, Poland
        • Poznan University of Medical Sciences
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom
        • Freeman Hospital
    • Middlesex
      • Harefield, Middlesex, United Kingdom, UB9 6JH
        • Harefield Hospital
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS2 9LN
        • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Implantation of the CARILLON Mitral Contour System
Device: CARILLON Mitral Contour System
Percutaneous mitral valve repair
Other Names:
  • CARILLON XE2
No Intervention: Control Group
Optimized stable medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in regurgitant volume associated with the CARILLON device relative to the Control population
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Document the difference in the rate of major adverse events between Treatment (CARILLON) and Control groups
Time Frame: 30 days and 12 months
30 days and 12 months
Assess rate of heart failure hospitalizations between Treatment (CARILLON) and Control groups
Time Frame: 12 months
12 months
Assess the change in six-minute walk distance between Treatment (CARILLON) and Control groups
Time Frame: 12 Months
12 Months
Assess the change in left ventricular volumes between Treatment (CARILLON) and Control groups
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiac Dimensions Pty Ltd

Collaborators

Menzies Institute for Medical Research

Investigators

  • Principal Investigator: Horst Sievert, MD, Cardio Vascular Center
  • Principal Investigator: David Kaye, MD, The Alfred

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

December 22, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 25, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVP 1627-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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