NCT02325830

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
8 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

August 22, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2020

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

August 5, 2024

Completed
Last Updated

August 5, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

December 22, 2014

Results QC Date

March 2, 2021

Last Update Submit

February 27, 2024

Conditions

Mitral Valve InsufficiencyHeart Failure

Keywords

Functional mitral regurgitationSecondary mitral regurgitationPercutaneous mitral repair

Outcome Measures

Primary Outcomes (2)

  • Change in Baseline Regurgitant Volume Associated With the Carillon Device Relative to the Control Population at 12 Months

    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.

    Baseline and 12 months

  • Difference in the Rate of Major Adverse Events Between Treatment (Carillon) and Control Groups

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

    Baseline and 12 months

Secondary Outcomes (3)

  • Rate of Heart Failure Hospitalizations Between Treatment (Carillon) and Control Groups

    Baseline and 12 months

  • Change in Six-minute Walk Distance Between Treatment (Carillon) and Control Groups

    Baseline and 12 Months

  • Change in Left Ventricular Volumes Between Treatment (Carillon) and Control Groups

    Baseline and 12 Months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Implantation of the Carillon Mitral Contour System

Device: Carillon Mitral Contour System

Control Group

NO INTERVENTION

Optimized stable medical therapy

Interventions

Carillon Mitral Contour SystemDEVICE

Percutaneous mitral valve repair

Treatment Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Royal Prince Alfred

Sydney, New South Wales, Australia

Location

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Alfred Health

Prahran, Victoria, 3181, Australia

Location

Prince Charles

Brisbane, Australia

Location

Olomouc University Hospital

Olomouc, Czechia

Location

Institut klinické a experimentální medicíny (IKEM)

Prague, Czechia

Location

Na Homolce Hospital

Prague, Czechia

Location

Pôle Sante République

Clermont-Ferrand, Auvergne, France

Location

Hôpital Privé Saint-Martin

Caen, 14000, France

Location

Clinique du Millénaire

Montpellier, France

Location

European Hospital Georges Pompidou

Paris, France

Location

Clinique Saint-Hilaire

Rouen, 76000, France

Location

Hôpital Charles Nicolle

Rouen, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

Märkische Kliniken GmbH, Klinikum Lüdenscheid

Lüdenscheid, North Rhine-Westphalia, 58515, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Augusta Kranken-Anstalt GmbH

Bochum, 44791, Germany

Location

Cardio Vascular Center Frankfurt

Frankfurt, Germany

Location

Klinikum Frankfurt Höchst GmbH

Frankfurt, Germany

Location

University Hospital Frankfurt

Frankfurt am Main, Germany

Location

Universitäts-Herzzentrum Freiburg

Freiburg im Breisgau, Germany

Location

Sana Kliniken Lübeck

Lübeck, Germany

Location

Elisabeth Krankenhaus GmbH

Recklinghausen, 45661, Germany

Location

Maastricht University Medical Centre

Maastricht, 6202 AZ, Netherlands

Location

Auckland City Hospital

Grafton, 1030, New Zealand

Location

Poznan University of Medical Sciences

Poznan, Poland

Location

Harefield Hospital

Harefield, Middlesex, UB9 6JH, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, LS2 9LN, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 19597051BACKGROUND

  • 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.

    PMID: 22613584BACKGROUND

  • 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.

    PMID: 19660613BACKGROUND

  • 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.

    PMID: 31521683DERIVED

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart Failure

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Vice President of Clinica Affairs
Organization
Cardiac Dimensions
aswenson@cardiacdimensions.com
425-605-5922

Study Officials

  • Horst Sievert, MD

    Cardio Vascular Center

    PRINCIPAL INVESTIGATOR

  • David Kaye, MD

    The Alfred

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: With crossover for sham procedure patients who are eligible at time of 12 month follow up.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2014

First Posted

December 25, 2014

Study Start

August 22, 2015

Primary Completion

July 1, 2018

Study Completion

January 8, 2020

Last Updated

August 5, 2024

Results First Posted

August 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)PL(1)FR(7)DE(9)GB(3)AU(6)NL(1)CZ(3)