Corvia Medical has announced that the first patient has been randomised in RESPONDER-HF, a global confirmatory trial of the Corvia atrial shunt in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction.
The first patient was enrolled and randomised by interventional cardiologist Scott Lilly and heart failure cardiologist Rami Kahwash (both Ohio State University Wexner Medical Center, Columbus, USA). “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,” commented Lilly.
Kahwash added: “Despite ongoing pharmaceutical advances, the treatment of HFpEF remains challenging, and multiple therapies are needed to treat such a heterogenous 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.”
RESPONDER-HF is a randomised, sham-controlled trial including up to 260 patients from 60 centres across the USA, Europe, and Australia. The trial will evaluate the efficacy of the Corvia Atrial Shunt to reduce HF hospitalisations and improve quality of life (QoL). Sanjiv Shah (Bluhm Cardiovascular Institute, Chicago, USA) and and Martin Leon (Columbia University Irving Medical Center, New York, USA) serve as lead investigators for the study.
The RESPONDER-HF confirmatory trial builds on scientific data and progressive learnings from REDUCE LAP-HF II, the largest randomized controlled trial of a device-based therapy for HFpEF patients. As published in Circulation, REDUCE LAP-HF II is the only study of an implantable therapeutic device to show clinical benefit in this population. Within the large responder group, 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 QoL compared to sham control.
“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 USA alone,” commented Leon. 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.”