Corvia Highlights Importance of Patient Selection in RESPONDER-HF Atrial Shunt Trial

April 12, 2024—Corvia Medical, Inc. announced that the recently presented data from the RELIEVE-HF trial support the evidence base for atrial shunt therapy. The Corvia atrial shunt device is being studied in the company’s global RESPONDER-HF trial.

The RELIEVE-HF findings were presented by Gregg Stone, MD, at ACC.24, the American College of Cardiology’s Annual Scientific Session held April 6-8 in Atlanta, Georgia. The study, which V-Wave Medical sponsored, is a randomized, placebo-procedure–controlled trial that evaluated interatrial shunting using V-Wave’s Ventura interatrial shunt. RELIEVE-HF included patients with both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF).

As reported in the ACC.24 press release, patients in RELIEVE-HF with heart failure who received the shunt did not see any significant benefits overall compared with those patients who received a placebo procedure after a median of 22 months of follow-up. The RELIEVE-HF investigators noted that although the trial did not meet its primary endpoint, it moves the field forward by offering signals that the benefits and risks of interatrial shunts may vary by heart failure type.

In its press release, Corvia Medical reiterated that the RELIEVE-HF results confirmed the importance of selecting patients with characteristics likely to benefit from atrial shunting versus those who will not.

Sanjiv Shah, MD, and Martin Leon, MD, who are coprincipal investigators of Corvia’s RESPONDER-HF trial, discussed these findings in the company’s press release.

Dr. Shah is Director of the HFpEF Program at Northwestern University School of Medicine in Chicago, Illinois. Dr. Leon is Director of Interventional Cardiovascular Care at Columbia University Irving Medical Center in New York, New York.

“Patient selection is critical, especially in HFpEF,” stated Dr. Shah in Corvia Medical’s press release. “We found in our last trial, REDUCE LAP-HF II, that HFpEF patients with pacemakers or pulmonary vascular disease didn’t benefit from atrial shunting. In our ongoing RESPONDER-HF trial, we are excluding those patients and using exercise hemodynamics to qualify and randomize HFpEF patients most likely to respond favorably to shunting.”

Dr. Leon added, “In this emerging field, it’s crucial to recognize the nuances of different studies with respect to patient demographics and trial methodologies to prevent misinterpretation of findings.”

He continued, “We know shunting is safe and has a positive effect in appropriately selected patients with HFpEF, and we have 3-year data to prove it. We’re confident the ongoing RESPONDER-HF trial will be a definitive step forward in bringing atrial shunt therapy to millions of HFpEF patients.”

In May 2023, Corvia announced the presentation of the 2-year results from its phase 3 REDUCE LAP-HF II randomized clinical trial at the European Society of Cardiology’s ESC Heart Failure 2023 conference in Prague, Czechia. The 2-year data confirmed the safety and sustained efficacy of the Corvia atrial shunt in properly selected heart failure patients with HFpEF or mildly reduced ejection fraction—HFmrEF, showing that patients who experienced a clinical benefit at 1 year continue to benefit at 2 years.

In late 2022, Corvia Medical announced the commencement of enrollment in RESPONDER-HF in late 2022. Information regarding RESPONDER-HF study eligibility is available online at treatmyheartfailure.com, advised Corvia Medical.