Corvia Atrial Shunt Evaluated in 2-Year Results From REDUCE LAP-HF II

May 22, 2023—Corvia Medical, Inc. announced 2-year results from its phase 3 REDUCE LAP-HF II randomized clinical trial confirming safety and sustained efficacy of the Corvia atrial shunt in properly selected heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. The findings confirmed that patients who experienced a clinical benefit at 1 year continue to benefit at 2 years.

The Corvia atrial shunt is designed to reduce elevated left atrial pressure, the primary contributor to heart failure symptoms in HFpEF patients, by creating a passage between the left and right atria, thereby reducing heart failure events and improving quality of life, advised the company.

The results were presented at the European Society of Cardiology’s ESC Heart Failure 2023 conference in Prague, Czechia.

According to the company, the study of 626 patients previously identified a responder group, representing half of all study participants, who experienced a significant reduction in heart failure events and an improvement in quality of life at 1 year. Importantly, the benefit was sustained in this group at the 2-year mark.

Patients with the Corvia atrial shunt showed a significant 50% reduction in the rate of heart failure events and a sustained improvement in quality of life compared to sham control, with 42% greater improvement in Kansas City Cardiomyopathy Questionnaire overall summary score, reported the company.

Finn Gustafsson, MD, who is Professor of Cardiology at the University of Copenhagen in Copenhagen, Denmark, commented in Corvia’s press release, “The 2-year REDUCE LAP-HF II findings demonstrate the longer-term safety of the Corvia atrial shunt and support what we observed at 1 year, that in properly selected patients, atrial shunting appears to have lasting clinical benefit in the reduction of heart failure events. This is the first longer-term, randomized data available for any atrial shunt device, and it continues to suggest that heart failure patients with more normal pulmonary vascular function are best suited for atrial shunting.”

Sanjiv Shah, MD, Coprincipal Investigator of the trial, added, “The 24-month results from the REDUCE LAP-HF II trial provide further assurance of the safety and efficacy of the Corvia atrial shunt. As ongoing global trials continue to advance our knowledge of atrial shunting, I remain optimistic that this device has the potential to deliver significant long-term benefits to a large proportion of heart failure patients.” Dr. Shah is from Northwestern University Feinberg School of Medicine in Chicago, Illinois.

Corvia Medical’s Chief Medical Officer, Jan Komtebedde, DVM, stated in the press release, “We are excited about the 2-year outcomes in the responder group as they provide strong evidence that we have successfully identified those heart failure patients who will benefit most from atrial shunting. We are currently recruiting patients into the RESPONDER-HF study, a confirmatory, randomized, sham-controlled trial at up to 60 centers across the United States, Europe, and Australia. We believe the results from this trial will provide the additional evidence required to make the therapy available to a broader patient population.” Information regarding RESPONDER-HF study eligibility is available at treatmyheartfailure.com.