Corvia Medical today announced positive data from the global phase III clinical trial of its atrial shunt in heart failure patients.
Tewksbury, Massachusetts-based Corvia published analyses from its global, phase III Reduce LAP-HF II randomized trial of heart failure (HF) patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction online in Circulation.
According to a news release, in a large responder population representing 50% of study patients, treatment with the Corvia atrial shunt resulted in a 45% reduction in HF events and a 55% greater improvement in quality of life compared to sham control.
Positive data will be welcome news for the company after, two months ago, Corvia reported that results from the same trial demonstrated that the atrial shunt device did not reduce heart failure rates or improve health status.
The company said the data also offers new insights into the role of exercise in accurately predicting patients who may or may not benefit from the novel therapy, which Corvia designed to reduce elevated left atrial pressure (LAP), the primary contributor of HF symptoms in HFpEF patients.
Corvia’s atrial shunt is placed via catheter between the left and right atria to create a passage through which blood is allowed to flow from the high-pressure left atrium to the lower-pressure right atrium. potentially reducing HF symptoms and events and improving quality of life.
Reduce LAP-HF II randomized 626 patients across 89 centers in the U.S., Canada, Europe, Australia and Japan, demonstrating the 45% reduction in HF events, 55% improvement in health status and a 50% greater improvement in New York Heart Association (NYHA) HF class, indicating fewer HF symptoms.
“The Corvia Atrial Shunt is the most rigorously studied atrial shunt therapy. Exercise hemodynamic evaluation has been a key component of all our studies and its importance in identifying suitable patients for atrial shunting has now been confirmed,” commented Jan Komtebedde, Senior Vice President and Chief Medical Officer at Corvia Medical. “We are working with advisors and regulators to design a confirmatory study that builds on the extensive data and progressive learnings from REDUCE LAP-HF II and we look forward to bringing this breakthrough therapy to the US and international markets to help this underserved population.”