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

Primary Purpose

Mitral Valve Insufficiency, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CARILLON Mitral Contour System
Sponsored by
Cardiac Dimensions Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring Functional mitral regurgitation, Secondary mitral regurgitation, Percutaneous mitral repair

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal North Shore Hospital
  • Royal Prince Alfred
  • Flinders Medical Centre
  • Monash Health
  • Alfred Health
  • Prince Charles
  • Olomouc University Hospital
  • Institut klinické a experimentální medicíny (IKEM)
  • Na Homolce Hospital
  • Pôle Sante République
  • Hôpital Privé Saint-Martin
  • Clinique du Millénaire
  • European Hospital Georges Pompidou
  • Clinique Saint-Hilaire
  • Hôpital Charles Nicolle
  • CHU Rangueil
  • Märkische Kliniken GmbH, Klinikum Lüdenscheid
  • Charité Universitätsmedizin Berlin
  • Augusta Kranken-Anstalt GmbH
  • University Hospital Frankfurt
  • Cardio Vascular Center Frankfurt
  • Klinikum Frankfurt Höchst GmbH
  • Universitäts-Herzzentrum Freiburg
  • Sana Kliniken Lübeck
  • Elisabeth Krankenhaus GmbH
  • Maastricht University Medical Centre
  • Auckland City Hospital
  • Poznan University of Medical Sciences
  • Harefield Hospital
  • Leeds Teaching Hospitals NHS Trust
  • Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

Implantation of the CARILLON Mitral Contour System

Optimized stable medical therapy

Outcomes

Primary Outcome Measures

Change in regurgitant volume associated with the CARILLON device relative to the Control population

Secondary Outcome Measures

Document the difference in the rate of major adverse events between Treatment (CARILLON) and Control groups
Assess rate of heart failure hospitalizations between Treatment (CARILLON) and Control groups
Assess the change in six-minute walk distance between Treatment (CARILLON) and Control groups
Assess the change in left ventricular volumes between Treatment (CARILLON) and Control groups

Full Information

First Posted
December 22, 2014
Last Updated
August 3, 2018
Sponsor
Cardiac Dimensions Pty Ltd
Collaborators
Menzies Institute for Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT02325830
Brief Title
CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation
Acronym
REDUCE FMR
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiac Dimensions Pty Ltd
Collaborators
Menzies Institute for Medical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency, Heart Failure
Keywords
Functional mitral regurgitation, Secondary mitral regurgitation, Percutaneous mitral repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
With crossover for sham procedure patients who are eligible at time of 12 month follow up.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Sievert, MD
Organizational Affiliation
Cardio Vascular Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Kaye, MD
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Royal Prince Alfred
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Alfred Health
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Prince Charles
City
Brisbane
Country
Australia
Facility Name
Olomouc University Hospital
City
Olomouc
Country
Czechia
Facility Name
Institut klinické a experimentální medicíny (IKEM)
City
Prague
Country
Czechia
Facility Name
Na Homolce Hospital
City
Prague
Country
Czechia
Facility Name
Pôle Sante République
City
Clermont Ferrand
State/Province
Auvergne
Country
France
Facility Name
Hôpital Privé Saint-Martin
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Clinique du Millénaire
City
Montpellier
Country
France
Facility Name
European Hospital Georges Pompidou
City
Paris
Country
France
Facility Name
Clinique Saint-Hilaire
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Märkische Kliniken GmbH, Klinikum Lüdenscheid
City
Lüdenscheid
State/Province
North Rhine-Westphalia
ZIP/Postal Code
58515
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Augusta Kranken-Anstalt GmbH
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
University Hospital Frankfurt
City
Frankfurt am Main
Country
Germany
Facility Name
Cardio Vascular Center Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Klinikum Frankfurt Höchst GmbH
City
Frankfurt
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg
City
Freiburg
Country
Germany
Facility Name
Sana Kliniken Lübeck
City
Lübeck
Country
Germany
Facility Name
Elisabeth Krankenhaus GmbH
City
Recklinghausen
ZIP/Postal Code
45661
Country
Germany
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Auckland City Hospital
City
Grafton
ZIP/Postal Code
1030
Country
New Zealand
Facility Name
Poznan University of Medical Sciences
City
Poznan
Country
Poland
Facility Name
Harefield Hospital
City
Harefield
State/Province
Middlesex
ZIP/Postal Code
UB9 6JH
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS2 9LN
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19597051
Citation
Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tubler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation. 2009 Jul 28;120(4):326-33. doi: 10.1161/CIRCULATIONAHA.109.849885. Epub 2009 Jul 13.
Results Reference
background
PubMed Identifier
22613584
Citation
Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012 Aug;14(8):931-8. doi: 10.1093/eurjhf/hfs076. Epub 2012 May 21.
Results Reference
background
PubMed Identifier
19660613
Citation
Siminiak T, Hoppe UC, Schofer J, Haude M, Herrman JP, Vainer J, Firek L, Reuter DG, Goldberg SL, Van Bibber R. Effectiveness and safety of percutaneous coronary sinus-based mitral valve repair in patients with dilated cardiomyopathy (from the AMADEUS trial). Am J Cardiol. 2009 Aug 15;104(4):565-70. doi: 10.1016/j.amjcard.2009.04.021. Epub 2009 May 29.
Results Reference
background
PubMed Identifier
31521683
Citation
Witte KK, Lipiecki J, Siminiak T, Meredith IT, Malkin CJ, Goldberg SL, Stark MA, von Bardeleben RS, Cremer PC, Jaber WA, Celermajer DS, Kaye DM, Sievert H. The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation. JACC Heart Fail. 2019 Nov;7(11):945-955. doi: 10.1016/j.jchf.2019.06.011. Epub 2019 Sep 11.
Results Reference
derived

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CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation

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