Study is the FirstBlinded, Randomized Clinical Trial Evaluating a Mitral Valve Repair Device inPatients with Functional Mitral Regurgitation
(Kirkland, Wash.), June 25, 2015—Cardiac Dimensions® today announced that thefirst patients have been enrolled in the REDUCE FMR clinical trial. REDUCE FMRis a prospective, double-blind, randomized multi-center trial, evaluating thecompany’s minimally-invasive CARILLON® Mitral Contour System®.
Involving up to 20 leading hospitals in Europe and Australia, REDUCE FMR willrandomize 120 patients and is designed to establish CARILLON as the goldstandard treatment for Functional Mitral Regurgitation (FMR) – a condition inwhich blood flow to the body is reduced due to an abnormally enlarged mitralvalve. All patients enrolled in the study are on an optimized heart failuremedication regimen and are then randomized into two groups: one additionallytreated with the CARILLON device and the second remaining on an optimizedregimen of heart failure medications, the present gold standard.
The study design contains some unique elements aimed at optimizing recruitmentand enrollment, including a 3:1 randomization ratio allowing for more data tobe collected with the CARILLON device and a cross-over registry which allowscontrol patients to receive CARILLON treatment at the end of their 12-monthfollow up. A built-in exercise echocardiographic sub-study will furtherevaluate the CARILLON device’s ability to reduce mitral regurgitation, improvefunctional capacity and quality of life as well as induce reverse ventricularremodeling in a symptomatic heart failure patient population both at rest andduring exercise.
The REDUCE FMR clinical trial follows three successful multi-center studies,featuring the CARILLON device – the AMADEUS, TITAN and TITAN II trials. “Myexperiences with CARILLON have been extremely positive. As an investigator inthe last two multi-center trials involving the CARILLON therapy I’ve seensignificant clinical improvement in patients who receive the device,” saidJanusz Lipiecki, M.D., of Clinique Pôle Santé République in Clermont Ferrand,France. “In this latest landmark trial, we expect to firmly establish themagnitude of benefit that patients receive from CARILLON.”
“The outcomes from REDUCE FMR will be added to the positive data alreadycollected from nearly 100 treated patients evaluated during the three previousprospective trials,” said Rick Stewart, Chief Executive Officer of CardiacDimensions. “This is the first randomized, blinded study in the field of FMR,making its results of critical importance in understanding the clinicalsignificance of the CARILLON device in this underserved patient population.”
About CARILLON® MitralContour System®
The CARILLON Mitral Contour System is a percutaneous mitral annuloplastytreatment option that can be deployed rapidly and safely1, utilizing standardinterventional techniques. The implantable device consists of a distal anchorand a proximal anchor connected by a shaping ribbon and utilizes the heart’svenous anatomy to reshape the mitral annulus. This approach allows forreduction of the dilated annulus, addressing a root cause of functional mitralregurgitation (FMR). CARILLON has demonstrated compelling efficacy,significantly improving patients’ symptoms, mitral regurgitation and quality oflife. In addition, all adjunctive treatment options remain available after usingCARILLON, making it an ideal first-line therapy for FMR.
About FunctionalMitral Regurgitation
An estimated 70 percent of the 26 million people worldwide with heart failuresuffer from functional mitral regurgitation (FMR). FMR typically results fromthe dilation of the left ventricle, which is the main pumping chamber in theheart. As the left ventricle increases in size, the mitral valve also expands.This dimensional increase leads to mitral regurgitation, which significantlyreduces the amount of blood flow out of the left ventricle and on to the bodyand its organs. FMR has been associated with high rates of mortality, reducedfunctional capacity, poor quality of life and an increase in patienthospitalizations. Current mainstream therapies to address FMR are limited. Amajority of patients become refractory to medical therapy, which is the currentstandard of care and traditional surgical intervention is associated with highrates of operative morbidity and mortality.
About CardiacDimensions
Cardiac Dimensions is a leader in the development of innovative, minimallyinvasive treatment modalities to address heart failure and relatedcardiovascular conditions. The company’s initial technology platform, theCARILLON Mitral Contour System has been designed to address functional mitralregurgitation, utilizing a novel percutaneous approach. Cardiac Dimensions hasoperations in Kirkland, Washington; Sydney, Australia and Frankfurt, Germany.For more information, visit the company’s web site: http://www.cardiacdimensions.com.
Cardiac Dimensions, CARILLON and Mitral Contour System are registeredtrademarks of Cardiac Dimensions.
For furtherinformation contact:
Cardiac Dimensions
Omari Bouknight
(425) 505-1455
Media Contact
Helen Winkler
(949) 606-2008
1 Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, ShahAM, Feldman T, Kaye DM, Goldberg S, Mehta N, Solomon SD, Levy WC, Reuter DG.Treatment of functional mitral regurgitation by percutaneous annuloplasty:Results of the TITAN Trial. Eur J Heart Fail. 2012;14:931-38.
