CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325830
• Other study ID #: CVP 1627-01
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Cardiac Dimensions Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Mitral Valve Insufficiency

Intervention

Device:
• CARILLON Mitral Contour System
Percutaneous mitral valve repair

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide	South Australia
Australia	Prince Charles	Brisbane
Australia	Monash Health	Clayton	Victoria
Australia	Alfred Health	Prahran	Victoria
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Australia	Royal Prince Alfred	Sydney	New South Wales
Czechia	Olomouc University Hospital	Olomouc
Czechia	Institut klinické a experimentální medicíny (IKEM)	Prague
Czechia	Na Homolce Hospital	Prague
France	Hôpital Privé Saint-Martin	Caen
France	Pôle Sante République	Clermont Ferrand	Auvergne
France	Clinique du Millénaire	Montpellier
France	European Hospital Georges Pompidou	Paris
France	Clinique Saint-Hilaire	Rouen
France	Hôpital Charles Nicolle	Rouen
France	CHU Rangueil	Toulouse
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Augusta Kranken-Anstalt GmbH	Bochum
Germany	Cardio Vascular Center Frankfurt	Frankfurt
Germany	Klinikum Frankfurt Höchst GmbH	Frankfurt
Germany	University Hospital Frankfurt	Frankfurt am Main
Germany	Universitäts-Herzzentrum Freiburg	Freiburg
Germany	Sana Kliniken Lübeck	Lübeck
Germany	Märkische Kliniken GmbH, Klinikum Lüdenscheid	Lüdenscheid	North Rhine-Westphalia
Germany	Elisabeth Krankenhaus GmbH	Recklinghausen
Netherlands	Maastricht University Medical Centre	Maastricht
New Zealand	Auckland City Hospital	Grafton
Poland	Poznan University of Medical Sciences	Poznan
United Kingdom	Harefield Hospital	Harefield	Middlesex
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds	Yorkshire
United Kingdom	Freeman Hospital	Newcastle upon Tyne

Sponsors (2)

Lead Sponsor	Collaborator
Cardiac Dimensions Pty Ltd	Menzies Institute for Medical Research

Countries where clinical trial is conducted

Australia,  Czechia,  France,  Germany,  Netherlands,  New Zealand,  Poland,  United Kingdom, 

References & Publications (3)

Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tübler 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in regurgitant volume associated with the CARILLON device relative to the Control population		12 months
Secondary	Document the difference in the rate of major adverse events between Treatment (CARILLON) and Control groups		30 days and 12 months
Secondary	Assess rate of heart failure hospitalizations between Treatment (CARILLON) and Control groups		12 months
Secondary	Assess the change in six-minute walk distance between Treatment (CARILLON) and Control groups		12 Months
Secondary	Assess the change in left ventricular volumes between Treatment (CARILLON) and Control groups		12 Months

External Links

•   Cardiac Dimensions - Current Clinical Studies