January 12, 2020
Corvia Medical's REDUCE LAP-HF II Global Clinical Trial Enrolls First Patients in Japan
January 13, 2020—Corvia Medical, Inc. announced commencement of the REDUCE LAP-HF II in Japan under a clinical trial authorization from the Pharmaceutical and Medical Device Agency. The first Japanese patients were randomized in Toyama and Hyogo.
The global pivotal clinical trial is evaluating the transcatheter Corvia interatrial shunt device (IASD) for treatment of heart failure with preserved ejection fraction (HFpEF) and midrange ejection fraction (HFmrEF). REDUCE LAP-HF II is a prospective, double-blind, sham-controlled clinical trial randomizing 608 HFpEF and HFmrEF patients in the United States, Europe, Australia, Japan, and Canada.
Professor Hiroyuki Tsutsui, MD, the trial’s Primary Investigator for Japan, commented in the company’s announcement, “The Japanese investigators are pleased to participate in REDUCE LAP-HF II, a global trial of the IASD for patients with HFpEF and HFmrEF, for which effective treatment strategies have not been established. We hope this landmark trial will be a great success and provide important clinical evidence regarding the efficacy and safety of this novel therapy.” Professor Tsutsui is with Kyushu University in Fukuoka, Japan.
Professor Koichiro Kinugawa, MD, and his heart team randomized the first patient at the University of Toyama Hospital. Hiroshi Ueno, MD, stated, “We are very proud to be the first hospital in Japan to randomize patients in the trial. Currently, there are limited treatment options for patients suffering from heart failure with preserved and midrange ejection fraction, and I am encouraged by the positive outcomes the Corvia IASD has provided in previous clinical studies."
Professor Masanori Asakura, MD, from the Hospital of Hyogo College of Medicine, added. “The Corvia IASD provides a much-needed therapeutic option for my heart failure patients. We are pleased to be a part of this landmark trial and we look forward to incorporating this technology into our heart failure treatment algorithm.”
In October 2019, the company announced that the Corvia IASD received FDA Breakthrough Device designation, underscoring its clinical significance and its potential to improve outcomes for heart failure patients, with the potential for accelerated market clearance in the United States.