One-Year Data Presented From REDUCE LAP-HF I Trial of Corvia Medical's IASD

August 27, 2018—Corvia Medical, Inc. announced 1-year follow-up data from the REDUCE LAP-HF I clinical study, which is evaluating the company’s transcatheter interatrial shunt device (IASD) for heart failure with preserved ejection fraction (HFpEF) and heart failure with mid-range ejection fraction (HFmrEF).

The study was presented by Ted Feldman, MD, at the European Society of Cardiology Congress 2018 held August 25–29 in Munich, Germany. The findings were simultaneously published by Sanjiv J. Shah, MD, et al in Journal of the American Medical Association: Cardiology. Dr. Feldman and Dr. Shah are the Coprincipal Investigators of the study.

According to Corvia Medical, REDUCE LAP-HF I is a prospective, double-blind, mechanistic study of 44 patients randomized to IASD or sham control. Primary study endpoints at 30 days included effectiveness of the IASD as measured by exercise pulmonary capillary wedge pressure (PCWP) reduction compared with sham control, and procedural safety as assessed by major adverse cardiovascular, cerebral, or renal events. The study met its primary endpoint.

The 1-year results demonstrate shunt patency for all participants who received the implant. Results further showed the IASD is safe, improved quality of life, and is associated with favorable trends in heart failure hospitalization and reduction in New York Heart Association class.

In the company's announcement, Dr. Feldman commented, "The REDUCE LAP-HF I clinical study is of tremendous interest to me because HFpEF is a clinical problem for which there is no effective therapy. We've now studied the IASD in several consecutive trials. The early single-arm studies demonstrated that people felt better and their exercise capacity improved. Now, a sham-controlled randomized study conclusively proves the mechanism of action and again suggests clinical efficacy in midterm follow-up."

Dr. Shah added, "I am pleased with the results of the REDUCE LAP-HF trials so far. By leading and taking part in these studies, we hope to make a significant difference for patients who suffer from the devastating effects of this type of heart failure."

Additionally, recruitment is being conducted in the REDUCE LAP-HF II, which is a large multinational prospective, double-blind, sham-controlled trial randomizing 608 patients with either HFpEF and HFmrEF. The trial seeks to demonstrate that the positive clinical outcomes from REDUCE LAP-HF 1 are robust enough to support this technology's introduction to clinical practice.

The IASD is an investigational device and not available for commercial distribution in the United States, advised Corvia Medical.