Cardiac Dimensions Announces Positive Late-Breaking Results for Blinded Clinical Trial of Minimally Invasive Heart Failure Treatment
In Randomized Blinded Study, the Carillon Mitral Contour System Catheter-Based Treatment Meets Endpoint for Reduction in Regurgitant Volume
KIRKLAND, WA — September 23, 2018 – Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, announced results of the company’s landmark REDUCE FMR clinical trial, which were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Diego.
The study met its primary endpoint, showing a statistically significant reduction in regurgitant volume at one year in patients who received the Carillon Mitral Contour System® versus the control cohort, consisting of patients under guideline-directed medical therapy who underwent a sham procedure. The reduction represented a 22% reduction in regurgitation in the treatment group, compared to an overall increase of 8% in regurgitation in the control group (p=0.03). Study patients, the imaging core lab, and the clinical assessors were blinded as to the patients’ randomization group through the one-year follow-up period of the study.
“I am impressed the trial results are consistent with the positive outcomes I’ve seen in my practice,” said Prof. Horst Sievert, MD, Director of the CardioVascular Center Frankfurt, Sankt Katharinen, and the Department of Internal Medicine, Cardiology, and Vascular Medicine of the Sankt Katharinen Hospital in Frankfurt, Germany, who presented the results at the conference. “When we designed this study, we knew a blinded, sham-controlled trial would be challenging, but the validity of the results would therefore be very compelling. And, it is.”
“We are pleased with these positive results, which come on the heels of enrollment of the first patient in our CARILLON Pivotal Trial, announced last week – the next step toward bringing the Carillon device to patients in the United States,” said Steve Goldberg, MD, Chief Medical Officer of Cardiac Dimensions. “We look forward to gathering further clinical evidence to increase our understanding of the benefits of the Carillon device.”
Marty Leon, MD, of Columbia University Medical Center/New York-Presbyterian Hospital, Chairman of the CARILLON steering committee, said, “The results of this unique but small, mechanistic trial are provocative. These data support and will inform the recently launched CARILLON trial, which is also a sham- controlled randomized trial, but it is a much larger pivotal trial with clinical endpoints.”
The REDUCE FMR study also showed those treated with the device experienced fewer major adverse events compared to the control group (16% vs. 18%, respectively). In addition, only 11% of the implanted patients experienced recurrent heart failure hospitalizations which was approximately half the 21% rate observed in the control group. However, the trial was not powered to make statistical conclusions in these endpoints.
Secondary analyses of heart remodeling (i.e. reduction of the size of the left ventricle over time) were also presented. The results showed a difference between those who received the Carillon device and those in the control group. Left ventricular end diastolic volumes were reduced in the treatment group, while the control group had an overall increase in volumes at 12 months (-8.6 vs +6.5, respectively; p=0.06). In addition, left ventricular end systolic volumes were reduced in the treatment group while the control group had an overall increase at 12 months (-4.8 vs +6.1, respectively; p=0.07).
Klaus Witte, MD, a heart failure physician from Leeds Teaching Hospital NHS Trusts, a top enroller in the REDUCE FMR study, commented, “Remodeling is important to patients as it has an impact on longer-term patient prognosis and mortality. The remodeling shown in the REDUCE FMR study is compelling and an important aspect to consider when contemplating treatment options for patients.”
The REDUCE FMR Trial included 120 heart failure patients who were randomized to treatment with the Carillon Mitral Contour System (N=87) or guideline-directed medical therapy (control) (N=33). The primary endpoint of the study was to show a significant change in regurgitant volume (a measurement of how much blood pumps back into the atrium) between the Carillon device and the guideline-directed medical therapy (GDMT) group at one year, as assessed by a blinded, independent echo core lab. Additional analyses of heart failure hospitalizations and product safety data were also presented at TCT.
The study’s age criteria was from 18 to 85 with a mean age of patients participating in the study of 70 years. Seventy-two percent (72%) were male, 60% had atrial fibrillation and 45% had been hospitalized for heart failure within one year prior to their enrollment in the study. The mean regurgitant volume was 39 ml.
About the Carillon Mitral Contour System
The Carillon Mitral Contour System is an innovative minimally invasive treatment for people diagnosed with FMR. The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression and prevent worsening quality of life. The Carillon System treats the dilated mitral annulus, the underlying mechanical problem of FMR, with a catheter-based alternative to medications and invasive surgery. The Carillon System is a minimally invasive approach that offers patients annular reduction, while keeping adjunctive therapy options open.
To date, approximately 900 patients have been treated with the Carillon System throughout the world. 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 the CE Mark demonstrating safety and performance. Additionally, the CARILLON Trial, the randomized sham-controlled U.S. pivotal IDE study, continues to enroll patients at centers in the U.S. and Europe.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. 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. Cardiac Dimensions has operations in Kirkland, Washington; Sydney, Australia and Frankfurt, Germany.
The Carillon Mitral Contour System is an investigational device in the U.S. For more information, please visit www.cardiacdimensions.com.
Cardiac Dimensions, Carillon and Mitral Contour System are registered trademarks of Cardiac Dimensions.
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NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.
CAUTION: Investigational Device. Limited by United States law to investigational use.