Feature | Heart Valve Technology | June 30, 2015

Initial Enrollments Made in REDUCE FMR Clinical Trial for Carillon Mitral Repair Device

Blinded, randomized clinical trial evaluating mitral valve repair device in patients with functional mitral regurgitation

REDUCE FMR, Cardiac Dimensions, Carillon Mitral Contour System, FMR

June 30, 2015 - Cardiac Dimensions announced the first patients have been enrolled in the REDUCE FMR clinical trial. REDUCE FMR is a prospective, double-blind, randomized multi-center trial, evaluating the company's minimally-invasive Carillon Mitral Contour System.

Involving up to 20 leading hospitals in Europe and Australia, REDUCE FMR will randomize 120 patients and is designed to establish Carillon as the gold standard treatment for functional mitral regurgitation (FMR) - a condition in which blood flow to the body is reduced due to an abnormally enlarged mitral valve. All patients enrolled in the study are on an optimized heart failure medication regimen and are then randomized into two groups: one additionally treated with the Carillon device and the second remaining on an optimized regimen of heart failure medications, the present gold standard.

The study design contains some unique elements aimed at optimizing recruitment and enrollment, including a 3:1 randomization ratio allowing for more data to be collected with the Carillon device and a crossover registry which allows control patients to receive Carillon treatment at the end of their 12-month follow up. A built-in exercise echocardiographic sub-study will further evaluate the device's ability to reduce mitral regurgitation, improve functional capacity and quality of life as well as induce reverse ventricular remodeling in a symptomatic heart failure patient population both at rest and during exercise.

The REDUCE FMR clinical trial follows three successful multi-center studies, featuring the Carillon device – the AMADEUS, TITAN and TITAN II trials. "My experiences with Carillon have been extremely positive. As an investigator in the last two multi-center trials involving the Carillon therapy I've seen significant clinical improvement in patients who receive the device," said Janusz Lipiecki, M.D., of Clinique Pí´le Santé République in Clermont Ferrand, France. "In this latest landmark trial, we expect to firmly establish the magnitude of benefit that patients receive from Carillon."

The Carillon Mitral Contour System is a percutaneous mitral annuloplasty treatment option that can be deployed rapidly and safely utilizing standard interventional techniques. The implantable device consists of a distal anchor and a proximal anchor connected by a shaping ribbon and utilizes the heart's venous anatomy to reshape the mitral annulus. This approach allows for reduction of the dilated annulus, addressing a root cause of FMR.

For more information: www.cardiacdimensions.com

Related Content

Ancora Heart Announces Positive Interim Analysis of AccuCinch Ventricular Repair System for Heart Failure
News | Heart Valve Technology | September 24, 2018
Ancora Heart Inc. announced positive clinical data from the company’s recently expanded U.S. early feasibility study...
Medtronic Announces TAVR Study of Aortic Stenosis Patients With Bicuspid Valves
News | Heart Valve Technology | September 19, 2018
The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a new...
4C Medical's AltaValve First-in-Human Experience to be Presented at TCT 2018
News | Heart Valve Technology | September 17, 2018
September 17, 2018 — 4C Medical Technologies Inc.
Gore Acquires Pipeline Medical Technologies Inc.
News | Heart Valve Technology | September 06, 2018
W. L. Gore & Associates Inc. (Gore) announced the acquisition of Pipeline Medical Technologies Inc., a privately...
The Edwards Lifesciences Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May.

The Edwards Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May, becoming the first transcatheter tricuspid repair device to be approved in the world.

Feature | Heart Valve Technology | August 21, 2018 | Jeff Zagoudis
The tricuspid valve has been dubbed “the forgotten valve” by many practitioners in the interventional cardiology spac
Earlier Intervention for Mitral Valve Disease May Lead to Improved Outcomes
News | Heart Valve Technology | July 26, 2018
The number of patients undergoing mitral valve operations are at an all-time high, and new research suggests many...
The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system  is being tested in the SUMMIT Trial.

The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system.

Feature | Heart Valve Technology | July 26, 2018
July 26, 2018 — The pivotal clinical study in the U.S.
A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

Feature | Heart Valve Technology | July 26, 2018
July 26, 2018 — A new multi-societal expert consensus document has been released that summarizes the position of thes
Abbott Receives FDA Approval for Third-Generation MitraClip Device
Technology | Heart Valve Technology | July 18, 2018
July 18, 2018 — Abbott announced it received approval from the U.S.
Videos | Heart Valve Technology | July 18, 2018
Jonathon Leipsic, M.D., FSCCT, professor of radiology and cardiology at the University of British Columbia, Vancouver
Overlay Init