News | Heart Failure | September 20, 2018

Cardiac Dimensions Randomizes First Patient in CARILLON Trial of Mitral Contour System

Multi-center study to evaluate minimally invasive treatment for functional mitral regurgitation


Cardiac Dimensions Randomizes First Patient in CARILLON Trial of Mitral Contour System

September 20, 2018 — Cardiac Dimensions announced the company has randomized its first patient in the CARILLON Pivotal Trial.

The CARILLON Trial is evaluating the Carillon Mitral Contour System for the treatment of functional mitral regurgitation (FMR) associated with heart failure (HF) as compared to a randomized control group treated with optimal medical management according to established heart failure guidelines. The multi-center, double-blinded, randomized controlled trial is expected to randomize 450 patients at up to 75 centers in North America and Europe. The trial has primary safety and efficacy endpoints at 12 months and will follow the randomized patients out to five years to document long-term safety and clinical status. The CARILLON Trial also includes a cross-over feature that allows patients originally randomized to the control group to receive the Carillon System after their one-year follow-up visit.

“Current treatments to improve the quality of life for patients with FMR fall short and many heart failure patients are too frail for open-heart surgery,” said Samir Kapadia, M.D., interventional cardiologist and cath lab director at the Heart & Vascular Institute, Cleveland Clinic, and one of the principal investigators of the CARILLON Trial. “Transcatheter treatments have been shown to be safe and effective in the treatment of valve diseases, but there is no minimally invasive intervention yet approved in the U.S. for these patients. Today, most FMR patients are treated with medical therapy only for decreasing symptoms but this does not address the underlying anatomical problem leading to mitral regurgitation. The CARILLON Trial should provide us a better understanding of the benefits of the Carillon System as an option for heart failure patients with FMR.”

Functional mitral regurgitation occurs when the left ventricle of the heart is enlarged, dilating (stretching) the valve opening (annulus) and causing a backward flow of blood into the atrium. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. Unlike other mitral regurgitation therapies, the Carillon System replicates traditional surgical standards through a minimally invasive approach that offers patients annular reduction, while keeping adjunctive therapy options open.

Commercially, the Carillon System has its CE Mark and is available in certain European markets as well as other key geographies including Turkey.  Clinical data from three completed studies of the Carillon System (AMADEUS, TITAN, and TITAN II) were the basis for CE marking demonstrating safety and performance. In addition, the company will announce the results of its landmark REDUCE FMR Trial — the first randomized, blinded evaluation of a therapy for FMR — at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 conference, Sept. 21-25 in San Diego.

Prof. Tomasz Siminiak, professor of cardiology at Poznan University of Medical Sciences in Poznań, Poland, randomized the first patient in the CARILLON Trial.

“We are very excited to participate in this landmark trial to study the Carillon System for patients with FMR,” said Siminiak. “These patients need access to less invasive treatment options, and to be able to contribute to advancements that have the potential to slow the progression of this chronic disease, is very important to us.”

An estimated 26 million people suffer from heart failure worldwide[1] and of those, approximately 70 percent have FMR. In the U.S., an estimated 2 million people are affected by symptomatic FMR associated with HF.[2],[3] Overall, HF is a significant clinical and economic burden with direct and indirect costs expected to grow to $70 billion by 2030.[4]

For more information:



[1] Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1:4–25. doi: 10.1002/ehf2.12005.

[2] Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-11.

[3] Patel JB, Borgeson DD, Barnes ME, el at. Mitral regurgitation in patients with advanced systolic heart failure. J Card Fail. 2004;10(4):285-91.

[4] Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the Impact of Heart Failure in the United States. Circ Heart Fail. 2013;6(3):606-19.


Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init