Cardiac Dimensions® Announces Launch of Its Optimized U.S. Pivotal Trial – The EMPOWER Trial
International Study to Evaluate Innovative Minimally Invasive Treatment for Heart Failure With Early-Stage Functional Mitral Regurgitation
KIRKLAND, WA — Aug. 20, 2021 — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the launch of the U.S. pivotal study The EMPOWER Trial.
The EMPOWER Trial is evaluating the Carillon Mitral Contour System® for the treatment of heart failure patients with early-stage functional mitral regurgitation (FMR). This blinded, randomized trial will compare the Carillon treatment to a sham-controlled group treated with optimal medical management according to established heart failure guidelines. During development of the trial design, Cardiac Dimensions analyzed an extensive amount of data from more than 250 study patients previously enrolled in over four similar trials. Based on these analyses, the device safety profile, and the company’s recent publications, the trial will focus on this extremely large patient population with limited other therapeutic alternatives.
Consistent with prior trials, Cardiac Dimensions will use third-party monitoring, core lab review and external safety reviews, which will produce the most scientifically rigorous clinical data to date in the investigation of heart failure patients with FMR. The combination of quality data, along with the trial being the only blinded, randomized, sham-controlled study performed in the mitral valve space, will make The EMPOWER Trial a landmark clinical study in the area of heart failure.
“The launch of our U.S. study represents a significant milestone for the company and big step forward to being able to offer the Carillon therapy to a patient population in need,” said Rick Wypych, Cardiac Dimensions President and Chief Executive Officer. “It’s interesting that despite just announcing the trial, we are already seeing overwhelming interest from our sites and the physician community, which is a clear testament to the need for additional device therapies for heart failure patients with early-stage FMR.”
The international trial is expected to randomize 300 patients at up to 75 sites. The study 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.
“I am very excited to launch The EMPOWER Trial,” said Samir Kapadia, M.D., interventional cardiologist, professor of medicine and chairman of the Department of Cardiovascular Medicine at Cleveland Clinic, and the national principal investigator of The EMPOWER Trial. “This will be the first time where we are able to study early intervention with a device in heart failure. The Carillon device will be used to treat heart failure patients with mild and moderate functional mitral regurgitation. This is an extremely large patient population that is currently not being studied by other novel therapies. It will be phenomenal to study the efficacy of the Carillon device in the EMPOWER trial— a rigorously designed, randomized, double blinded, and sham-controlled multicenter clinical trial.”
About the Carillon Mitral Contour System
Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure (HF) by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System®, is a groundbreaking, non-surgical device developed to treat patients with mitral valve insufficiency in a safe and effective manner. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy can also be used alongside other HF treatments should they be needed.
To date, over 1,500 patients have been treated with the Carillon System throughout the world. Clinical data from over 250 patients in four previously completed studies of the Carillon System have provided the basis for demonstrating the safety and performance of the Carillon device as well as for the related CE Mark, which allows for commercial sales in Europe. Additionally, the U.S. pivotal study, The EMPOWER Trial, is currently enrolling patients worldwide.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address HF and related cardiovascular conditions. Left untreated, FMR contributes to HF—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 approved for sale in Europe through its CE Mark and is an investigational device in the U.S. For more information, please visit cardiacdimensions.com.
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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.