Pivotal Trial Begins for Corvia Medical's IASD System for the Treatment of Heart Failure
November 14, 2017—Corvia Medical, Inc. announced that it has enrolled the first patients in its global, multicenter REDUCE LAP-HF II trial of the company's IASD interatrial shunt device system for the treatment of heart failure. The company also advised that results from the randomized REDUCE LAP-HF I feasibility trial will be presented at the American Heart Association (AHA) 2017 scientific sessions held November 11–15 in Anaheim, California.
According to Corvia, the REDUCE LAP-HF II trial is a prospective, multicenter, double-blind randomized controlled trial to evaluate the IASD system to reduce elevated left atrial pressure in patients with heart failure with preserved or midrange ejection fraction. The study will enroll patients at up to 70 sites in the United States and up to 30 sites outside the United States. Sanjiv Shah, MD, and Ted Feldman, MD, serve as Coprincipal Investigators for the study. Rami Kahwash, MD, enrolled the first patient in the REDUCE LAP-HF II trial, which will support US Food and Drug Administration approval of the IASD system.
On November 15, Dr. Shah is presenting results from the randomized REDUCE LAP-HF I feasibility trial during the Innovative Therapies and Novel Applications session of the Late-Breaking Science program of the AHA meeting.
In Corvia's announcement, Dr. Shah commented, “The treatment of heart failure with preserved ejection fraction is challenging, and caring for these patients can be frustrating. Multiple randomized drug trials have demonstrated that conventional heart failure medications are ineffective in this type of heart failure, and as a result, patients have limited therapeutic options.”
Dr. Kahwash added, “Since heart failure symptoms are directly linked to elevated left atrial pressures, the interatrial shunt device has the potential to offer an effective treatment by facilitating continuous and dynamic decompression of the left atrium, subsequently reducing symptoms and improving quality of life for this patient population.”
Dr. Feldman stated, “Having experience with the IASD in prior studies, I have substantial appreciation for the elegance of the implant procedure and have been very satisfied with the positive effect it has had. The open-label study showed that following IASD implantation, patients had significantly fewer heart failure symptoms and could exercise significantly longer, giving them a substantially better quality of life. We are pleased to be part of the pivotal study and continue to offer this innovative treatment to our heart failure patients.”