MORGANTOWN, W.Va. – The WVU Heart and Vascular Institute today announced that it is the first center in West Virginia to enroll patients in the RESPONDER-HF trial evaluating the effectiveness of the Corvia Atrial Shunt, an investigational cardiac implant designed to address the frequent hospitalizations and symptoms that limit quality of life in people suffering from heart failure.
The randomized trial will be offered to patients with preserved ejection fraction (HFpEF), the most common type of heart failure, but one for which effective treatments are limited.
“Treating heart failure patients who remain symptomatic despite guideline-directed medical therapy is challenging and often frustrating because standard treatments, especially those for patients with HFpEF, have limitations in efficacy,” Vikrant Jagadeesan, M.D., interventional cardiologist and assistant professor at the WVU Heart and Vascular Institute, said. “Participating in RESPONDER-HF provides heart failure patients access to a novel, minimally invasive treatment option that has the potential to relieve their breathlessness and fatigue and give them a better quality of life.”
More than 26 million people worldwide have HF, and over half of those have HFpEF, which has been described as the largest unmet clinical need in cardiovascular medicine.
The Corvia Atrial Shunt is a novel cardiac implant that is part of a HF treatment class called interatrial shunting. It is designed to reduce elevated left atrial pressure (LAP), the primary contributor of HF symptoms in HFpEF patients. The shunt is placed via catheter between the left and right atria, forming a passage that allows blood to flow from the high pressure left atrium to the lower pressure right atrium, with the aim of reducing HF symptoms and hospitalizations, thereby lowering the overall cost of managing HF and improving overall functional status and quality of life.
About the Corvia Atrial Shunt and RESPONDER-HF – The Corvia Atrial Shunt is the most clinically studied atrial shunt for the reduction of LAP in symptomatic HF patients. It has been implanted in over 550 patients worldwide and reviewed in over 20 academic publications. The RESPONDER-HF trial builds on the extensive data and progressive learnings from the REDUCE LAP-HF II clinical trial, the largest randomized controlled trial of device-based therapy in HFpEF. Results showed that within a large responder population, representing 50 percent of study patients, treatment with the Corvia Atrial Shunt resulted in a 45 percent reduction in HF events and a 55 percent greater improvement in quality of life compared to sham control.
RESPONDER-HF is a randomized, double-blind, sham-controlled trial including up to 260 patients from centers across the U.S., Canada, Europe, and Australia. Drs. Sanjiv Shah from Northwestern Memorial Hospital’s Center for Heart Failure and Dr. Martin Leon from Columbia University Irving Medical Center serve as co-principal investigators for the study. For more information, visit TreatMyHeartFailure.com.
