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

A Sapien 3 TAVR valve in position as seen under GE Assist guidance on angiography. Study Finds Sustained Benefit for TAVR vs. SAVR at One Year. #TCT2019 #TCT19

A Sapien 3 TAVR valve in position as seen under GE Assist guidance on angiography.

News | Heart Valve Technology | October 04, 2019
October 4, 2019 – A new analysis of the PARTNER 3 Trial data found a modest, but significant, improvement in one-year
Five-year results from the PARTNER 2A Trial found patients with severe aortic stenosis (AS) and intermediate surgical risk who underwent Sapien 3 transcatheter aortic valve replacement (TAVR) had similar rates of death and disabling stroke compared to those who had surgical aortic valve replacement (SAVR). However, TAVR using a transthoracic approach had poorer outcomes compared to SAVR. #TCT2019
News | Heart Valve Technology | October 03, 2019
October 3, 2019 – Five-year results from the PARTNER 2A Trial found patients with severe aortic stenosis (AS) and int
The Boston Scientiofic Acurate Neo TAVR valve did not meet non-inferiority to the Sapien 3 valve in patients with severe aortic stenosis. #TAVR #TCT2019
News | Heart Valve Technology | October 02, 2019
October 2, 2019 – The first randomized trial to compare the safety and efficacy of the new Boston Scientific Acurate
The Portico FDA investigational device exemption (IDE) study found that 30-day safety and one-year effectiveness outcomes of a novel self-expanding transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis (AS) at high or extreme-risk for surgery was noninferior to contemporary FDA-approved TAVR systems. #TAVR #TCT2019
News | Heart Valve Technology | October 02, 2019
October 2, 2019 – The Abbott Portico FDA investigational device exemption (IDE) study found that 30-day safety and on
Medtronic Launches Evolut Pro+ TAVR System
Technology | Heart Valve Technology | September 24, 2019
Medtronic announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Evolut Pro+ transcatheter...
Reducing Secondary Mitral Regurgitation in Heart Failure Does Not Improve Two-year Outcomes
News | Heart Valve Technology | September 11, 2019
Percutaneous reduction of secondary mitral regurgitation in patients with heart failure does not lower death and...
Abbott Launches Pivotal Trial of TriClip Tricuspid Valve Repair System
News | Heart Valve Technology | September 05, 2019
Abbott announced the launch of the company's TRILUMINATE Pivotal trial evaluating the safety and effectiveness of its...
An illustration of the BASILICA procedure showing the leaflet of the original bioprosthetic valve sliced open to allow coronary blood flow after implantation of a TAVR valve. The new TAVR valve can push the leaflets of the bioprosthetic valve upwards, blocking the coronary arteries. During the BASILICA procedure, a catheter directs an electrified guidewire through the base of the left aortic cusp into a snare in the left ventricular outflow tract (LVOT). After snare retrieval, the mid-shaft of the guidewire

An illustration of the BASILICA procedure showing the leaflet of the original bioprosthetic valve sliced open to allow coronary blood flow after implantation of a TAVR valve. The new TAVR valve can push the leaflets of the bioprosthetic valve upwards, blocking the coronary arteries. During the BASILICA procedure, a catheter directs an electrified guidewire through the base of the left aortic cusp into a snare in the left ventricular outflow tract (LVOT). After snare retrieval, the mid-shaft of the guidewire is electrified to lacerate the leaflet, and the the leaflet splays after TAVR permitting coronary flow.

Feature | Heart Valve Technology | August 27, 2019
A novel technique has proven successful in preventing coronary artery obstruction during transcatheter aortic valve r
Overlay Init