Corvia Medical has announced the publication of two-year echocardiographic data from its REDUCE LAP-HF II randomised clinical trial of the Corvia atrial shunt in JAMA Cardiology.
The study demonstrated favourable long-term effects of atrial shunting on heart structure and function in patients with heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF), the company said in a press release. Analysis showed that atrial shunting led to favourable cardiac remodelling, restoration of the heart’s normal function, with resulting improvements in clinical outcome and prognosis.
The analysis also demonstrated more favourable remodelling in previously defined responders compared to non-responders, confirming that patients with no latent pulmonary vascular disease and no cardiac pacemaker are most likely to benefit from atrial shunt therapy.
“We now have two-year evidence of reverse remodelling in patients with an atrial shunt, with more pronounced improvements in cardiac structure and function—and associated clinical benefit—in previously defined responders versus non-responders,” said Sanjiv Shah (Northwestern University School of Medicine, Chicago, USA) lead investigator for the study. “This data not only offers insight into the long-term effects of atrial shunting but also represents the largest and most comprehensive echocardiographic follow-up study of any device or pharmacological trial in HFpEF and HFmrEF to date.
“The findings of our study support the referral of suitable patients to RESPONDER-HF, a randomised, sham-controlled trial now underway in the USA, Europe and Australia in pursuit of the evidence required to achieve US Food and Drug Administration (FDA) approval of the Corvia atrial shunt for millions of heart failure patients.”
