Medical researchers have kept busy in recent years developing new interventional treatments for heart failure that offer more relief than guideline-directed medical therapy (GDMT) without requiring a left ventricular assist device (LVAD). or heart transplant. Cleveland Clinic Interventional Cardiologists Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institutefor example, are involved in multiple clinical trials exploring these promising therapies.
The Cleveland Clinic, consistently 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 transplantation can be vast and difficult”.
1. The Carillon mitral contour system (cardiac dimensions)
the EMPOWER focuses on the Carillon Mitral Contour System of Heart dimensions, which has already obtained CE mark approval in Europe for the treatment of functional mitral regurgitation (MR). This device is placed in the right heart using transcatheter access through the jugular vein; it was designed to improve heart function by reshaping the patient’s mitral valve annulus and reducing mitral annular dilation.
Samir Kapadia, MD, an interventional cardiologist and Cleveland Clinic Chair in Cardiovascular Medicine, is helping lead the EMPOWER trial. He and his team hope to recruit a total of 300 heart failure patients 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 new therapies,” Kapadia said.
2. The AccuCinch Ventricular Restoration System (Ancora Heart)
the CORCINCH-HF the study is centered on Ancora Heart AccuCinch Ventricular Restoration System, an interventional device that is implanted using transfemoral access and “squeezes” the upper part of the patient’s heart. Implantation follows a workflow comparable to transcatheter mitral annuloplasty procedures.
Rishi Puri, MD, PhD, an interventional cardiologist at the Cleveland Clinic, is participating in the study, which is designed to include 400 patients from 80 different institutions. AccuCinch and GDMT results will be compared to GDMT results only. Patients will be followed for at least two years.
“The goal is to reduce left ventricular wall stress and dimensions, initiating a biological process of reverse remodeling to improve myocardial contractility and overall function,” Puri said. “This should improve patient quality of life and survival, increase exercise capacity, and reduce heart failure hospitalizations.”