Corvia has announced completion of randomisation in its REDUCE LAP-HF II global, pivotal trial. The trial is evaluating the Corvia atrial shunt (IASD)—a novel, transcatheter implant—to reduce elevated left atrial pressures (LAP), the primary cause of HF symptoms, in heart failure patients with preserved ejection fraction (HFpEF) or mid-range ejection fraction (HFmrEF). The company also announced authorisation by the US Food and Drug Administration (FDA) to continue evaluation of the Corvia Atrial Shunt under a Continued Access Protocol (CAP) while its pre-market approval (PMA) application is under review. PMA submission is planned for late 2021.
REDUCE LAP-HF II is a large, prospective, multicentre, randomised, sham-controlled trial to evaluate interatrial shunting. The study randomised 626 patients at 109 sites across 15 countries, with the aim to improve quality of life, reduce HF symptoms and decrease HF-related hospitalisations. Primary outcome measures will be evaluated after the last randomised patient completes 12-month follow-up. Sanjiv Shah from Northwestern University Feinberg School of Medicine, Chicago, US, and Martin Leon, from the Columbia University Irving Medical Center, New York, USA serve as lead principal investigators.
“The outcome of the landmark REDUCE LAP-HF II trial has the potential to revolutionise how we treat these heart failure patients, which is the greatest unmet need in cardiology today,” stated Shah. “Treating this population is challenging, and often frustrating, because standard treatments for heart failure don’t work well. Data from this study evaluating the efficacy of the Corvia Atrial Shunt will provide valuable information regarding this novel therapy in this underserved patient population.”
Leon added: “In light of the increasing incidence of heart failure, innovative treatment options are of critical importance. We are pleased with the study execution and enrolment pace of this trial, and are eagerly awaiting the results, which have the potential to change the treatment paradigm for heart failure.”
“Randomising the last pivotal trial patients is a significant milestone for Corvia and brings us one step closer to providing this innovative technology to patients in the USA,” said George Fazio, president and CEO of Corvia Medical. “REDUCE LAP-HF II is one of the largest randomised heart failure device trials ever undertaken and demonstrates our commitment to building a strong body of clinical evidence showing how atrial shunting advances care for patients suffering with the debilitating symptoms of heart failure.”
Corvia also announced FDA authorisation to continue patient enrolment under a CAP. The open label REDUCE LAP-HF IV study will enrol patients at existing pivotal trial centres. “We are pleased to have the opportunity to continue to offer this breakthrough therapy to heart failure patients,” said Jan Komtebedde, senior vice president and chief medical officer at Corvia Medical. “In collaboration with our advisors and investigators, we are committed to generating unbiased evidence to support this new therapeutic class of atrial shunting for heart failure. This study provides an opportunity to generate additional safety and efficacy evidence to support future therapy adoption.”