Tewksbury, Massachusetts-based Corvia designed its shunt for heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction.
Dr. Scott Lilly and Dr. Rami Kahwash enrolled and randomized the first patient at the Ohio State University Wexner Medical Center. In a news release, Lilly noted that atrial shunt therapy could “represent significant clinical benefit” for millions of patients.
“Despite ongoing pharmaceutical advances, the treatment of HFpEF remains challenging, and multiple therapies are needed to treat such a heterogenous disease,” said Kahwash. “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.”
Corvia intends to enroll up to 260 patients across 60 centers in the randomized, sham-controlled trial. Center locations include the U.S., Europe and Australia. The trial evaluates the efficacy of the atrial shunt in reducing HF hospitalizations and improving quality of life.
Dr. Sanjiv Shah and Dr. Martin Leon serve as lead investigators for the study. Shah, director of research for the Bluhm Cardiovascular Institute, also directs the HFpEF program at Northwestern University Feinberg School of Medicine. Leon serves as director of interventional cardiovascular care at Columbia University Irving Medical Center.
The trial builds on data collected from Corvia’s Reduce LAP-HF II trial. In April, Corvia published positive results from the global, phase III randomized trial for the atrial shunt.
Just two months prior, Corvia reported negative results from the same trial. Data demonstrated that the atrial shunt device failed to reduce heart failure rates. It also failed to improve health status.
Shah said the trial may help to potentially “change the treatment paradigm” in heart failure.