Medical researchers have stayed busy in recent years working to develop new interventional heart failure treatments that offer more relief than guideline-directed medical therapy (GDMT) without requiring a left ventricular assist device (LVAD) or heart transplant. The interventional cardiologists at Cleveland Clinics Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute, for instance, are involved in multiple clinical trials exploring these promising therapies.
Cleveland Clinic, regularly voted the No. 1 heart hospital in the United States, provided an update on some of these trials, noting that the treatment landscape between GDMT and LVAD placement or heart transplant can be broad and challenging.
The EMPOWER trial is focused on the Carillon Mitral Contour System from Cardiac Dimensions, which has already gained CE mark approval in Europe for treating functional mitral regurgitation (MR). This device is place in the right heart using transcatheter access through the jugular vein; it was designed to improve heart function by reshaping the patients mitral valve annulus and reducing mitral annular dilation.
Samir Kapadia, MD, an interventional cardiologist and Cleveland Clinics chair of cardiovascular medicine, is helping lead the EMPOWER trial. He and his team hope to enroll a total of 300 patients who have heart failure with mild functional MR. Patients will be randomized to receive either the Carillon device or a sham device, and they will be followed for a planned total of five years.
This is an extremely large patient population that is not currently being addressed by studies of other novel therapies, Kapadia said.
The CORCINCH-HF study is focused on Ancora Hearts AccuCinch Ventricular Restoration System, an interventional device that is implanted using transfemoral access and clinches the upper part of the patients heart. Implantation follows a workflow comparable to transcatheter mitral annuloplasty procedures.
Rishi Puri, MD, PhD, an interventional cardiologist with Cleveland Clinic, is taking part in the study, which is designed to include 400 patients from up to 80 different facilities. Outcomes from the AccuCinch and GDMT together will be compared with outcomes from just GDMT. Patients will be followed for at least two years.
The aim is to reduce left ventricular wall stress and dimensions, initiating a biologic process of reverse remodeling to improve myocardial contractility and overall function, Puri said. This should improve the patients quality of life and survival, increase exercise capacity and reduce heart failure hospitalizations.
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