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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02325830




Registration number
NCT02325830
Ethics application status
Date submitted
22/12/2014
Date registered
25/12/2014
Date last updated
7/08/2018

Titles & IDs
Public title
CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation
Scientific title
The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System® in Reducing Functional Mitral Regurgitation (FMR) Associated With Heart Failure
Secondary ID [1] 0 0
CVP 1627-01
Universal Trial Number (UTN)
Trial acronym
REDUCE FMR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Valve Insufficiency 0 0
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CARILLON Mitral Contour System

Experimental: Treatment Group - Implantation of the CARILLON Mitral Contour System

No Intervention: Control Group - Optimized stable medical therapy


Treatment: Devices: CARILLON Mitral Contour System
Percutaneous mitral valve repair
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in regurgitant volume associated with the CARILLON device relative to the Control population
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Document the difference in the rate of major adverse events between Treatment (CARILLON) and Control groups
Timepoint [1] 0 0
30 days and 12 months
Secondary outcome [2] 0 0
Assess rate of heart failure hospitalizations between Treatment (CARILLON) and Control groups
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Assess the change in six-minute walk distance between Treatment (CARILLON) and Control groups
Timepoint [3] 0 0
12 Months
Secondary outcome [4] 0 0
Assess the change in left ventricular volumes between Treatment (CARILLON) and Control groups
Timepoint [4] 0 0
12 Months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2018
Sample size
Target
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
Royal Prince Alfred - Sydney
Recruitment hospital [3] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [4] 0 0
Monash Health - Clayton
Recruitment hospital [5] 0 0
Alfred Health - Prahran
Recruitment hospital [6] 0 0
Prince Charles - Brisbane
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
5042 - Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3181 - Prahran
Recruitment postcode(s) [6] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Olomouc
Country [2] 0 0
Czechia
State/province [2] 0 0
Prague
Country [3] 0 0
France
State/province [3] 0 0
Auvergne
Country [4] 0 0
France
State/province [4] 0 0
Caen
Country [5] 0 0
France
State/province [5] 0 0
Montpellier
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
France
State/province [7] 0 0
Rouen
Country [8] 0 0
France
State/province [8] 0 0
Toulouse
Country [9] 0 0
Germany
State/province [9] 0 0
North Rhine-Westphalia
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Bochum
Country [12] 0 0
Germany
State/province [12] 0 0
Frankfurt am Main
Country [13] 0 0
Germany
State/province [13] 0 0
Frankfurt
Country [14] 0 0
Germany
State/province [14] 0 0
Freiburg
Country [15] 0 0
Germany
State/province [15] 0 0
Lübeck
Country [16] 0 0
Germany
State/province [16] 0 0
Recklinghausen
Country [17] 0 0
Netherlands
State/province [17] 0 0
Maastricht
Country [18] 0 0
New Zealand
State/province [18] 0 0
Grafton
Country [19] 0 0
Poland
State/province [19] 0 0
Poznan
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Middlesex
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Yorkshire
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cardiac Dimensions Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Menzies Institute for Medical Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02325830
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Horst Sievert, MD
Address 0 0
Cardio Vascular Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries