Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced impressive three-year results from its REDUCE LAP-HF II randomized clinical trial confirming safety and sustained efficacy of the Corvia® Atrial Shunt in selected heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. The results were published in The American Heart Journal.
REDUCE LAP-HF II is the world’s first phase III trial to evaluate safety and efficacy of an atrial shunt in heart failure patients. The study of 626 patients previously identified a responder group representing half of all study participants. This group consisted of patients without latent pulmonary vascular disease or a cardiac rhythm management device.
At three years, the 161 responder patients receiving the Corvia Atrial Shunt experienced 44% fewer combined inpatient and outpatient heart failure events compared to the control group of 152 patients. The shunt group also reported a clinically meaningful 2.5 times greater improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, indicating improved quality of life with less fatigue, reduced shortness of breath, and fewer activity restrictions. No significant safety concerns have been identified with the Corvia Atrial Shunt.
Original Paper:
https://www.sciencedirect.com/science/article/abs/pii/S0002870324002163
