US-based medical equipment manufacturer Corvia Medical has unveiled analyses showing positive results for its Atrial Shunt, from Phase 3 REDUCE LAP-HF II trial in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction.

The REDUCE LAP-HF II trial has enrolled 626 participants at 89 centres across the US, Canada, Europe, Australia, and Japan.

In the study, around 50% of participants who received Corvia Atrial Shunt experienced a 45% reduction in HF events, and a 55% improvement in quality of life, compared to sham control.

In addition, the data offers new insights into the role of exercise in accurately predicting patients who may or may not benefit from the novel therapy.

REDUCE LAP-HF II trial co-principal investigator Sanjiv Shah said: “We are extremely encouraged by these analyses from the REDUCE LAP-HF II trial.

“Not only have we identified a large responder group comprising two-thirds of people with HFpEF, or approximately 2 million people in the US alone, but we have also learned how to identify potential patients who are most likely to derive significant benefit.”

Corvia said that its Atrial Shunt has been designed to reduce elevated left atrial pressure (LAP), the primary contributor of HF symptoms in HFpEF patients.

The shunt is placed via a catheter between the left and right atria, to allow blood flow from the high pressure left atrium to the lower pressure right atrium, and reduce HF symptoms.

The independent analysis of the study found that patients with exercise pulmonary vascular resistance (PVR) and the presence of a pacemaker will affect how patients respond to atrial shunting.

In the study results, the patients without a pacemaker and with normal exercise PVR comprised 50% of the total study population and derived significant clinical benefits.

REDUCE LAP-HF II is the largest randomised controlled trial (RCT) of a device-based therapy for HFpEF patients in this population, said Corvia Medical.

Corvia Medical senior vice president and chief medical officer Jan Komtebedde said: “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.

“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.”