First Patient Enrolled in RESPONDER-HF Trial Evaluating Corvia Medical’s Atrial Shunt for Heart Failure

December 8, 2022—Corvia Medical, Inc. recently announced that the first patient was randomized in RESPONDER-HF, a clinical trial evaluating the company’s Corvia atrial shunt in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction.

The patient was enrolled at the Ohio State University Wexner Medical Center by Scott Lilly, MD, and Rami Kahwash, MD.

“We are pleased to participate in RESPONDER-HF and continue the important work of studying atrial shunt therapy, which may represent significant clinical benefit for millions of heart failure patients,” said Dr. Lilly, an interventional cardiologist at the medical center, in the company’s press release.

Dr. Kahwash, a heart failure cardiologist, added, “Despite ongoing pharmaceutical advances, the treatment of HFpEF remains challenging, and multiple therapies are needed to treat such a heterogeneous disease. We are pleased to offer access to a novel treatment option that has the potential to relieve our patients’ breathlessness and improve their quality of life (QOL).”

According to the company, RESPONDER-HF is a randomized, sham-controlled trial including up to 260 patients from 60 centers across the United States, Europe, and Australia. The trial will evaluate the efficacy of the Corvia atrial shunt to reduce heart failure hospitalizations and improve QOL.

Sanjiv Shah, MD, Director of Research for the Bluhm Cardiovascular Institute and Director of the HFpEF Program at Northwestern University Feinberg School of Medicine, and Martin Leon, MD, Director of Interventional Cardiovascular Care at Columbia University Irving Medical Center, serve as lead investigators for the study.

“We are committed to demonstrating the potential benefit of atrial shunt therapy and anticipate RESPONDER-HF will validate the REDUCE LAP-HF II responder group findings, which correspond to two-thirds of people with HFpEF, or 2 million people in the United States alone,” commented Dr. Leon in the company’s announcement.

Dr. Shah further added, “The RESPONDER-HF trial will not only continue to advance our scientific understanding of shunting in HFpEF but also has the potential to change the treatment paradigm, and in doing so, move us one step closer to precision medicine in heart failure.”

The company explained that the Corvia atrial shunt is designed to reduce elevated left atrial pressure, the primary contributor of heart failure symptoms in HFpEF patients. The shunt is placed via a 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 events and improving QOL.

Corvia Medical noted that the RESPONDER-HF confirmatory trial aims to build on the data and learnings from REDUCE LAP-HF II, the largest randomized controlled trial of a device-based therapy for HFpEF patients.