October 8, 2019
REVIVE-HF European RCT Commences for BioVentrix' Revivent TC System
October 8, 2019—BioVentrix, Inc. announced that the first patient was enrolled and treated in the REVIVE-HF European study.
REVIVE-HF is a prospective multicenter, dual-arm randomized controlled study evaluating the treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC system compared with guideline-directed medical therapy (GDMT) or drug treatment.
The principal investigator for REVIVE-HF is Professor Volkmar Falk, MD, of Deutsches Herzzentrum Berlin in Berlin, Germany, where the first patient in the trial was treated. The trial plans to enroll 180 patients, with 120 patients to be treated with the Revivent TC system and 60 patients to be maintained on GDMT. Its primary endpoint is improvement in heart failure symptoms based on a 6-minute walking test.
According to the company, the Revivent TC system is intended for use in patients who have had a myocardial infarction (MI) creating a left ventricular scar, resulting in an enlarged left ventricle causing heart failure symptoms. These symptoms include fatigue, shortness of breath, and/or physical limitations despite ongoing treatment.
The system offers patients with abnormally dilated hearts the benefits of reducing the dilated heart by less invasively excluding scar from the healthy tissue on the left ventricle with its anchoring technology. The result is decreased systolic volume providing increased efficiency of the left ventricle.
The first patient in the trial had an MI resulting in scarring in the left ventricle and subsequently developed ischemic heart failure and was implanted with three anchor pairs.
Prof. Falk noted that the enrollment marks a significant milestone validating the Revivent TC transcatheter ventricular enhancement system to become an important treatment option for ischemic heart failure with reduced ejection fraction patients. He stated further in the company’s announcement, "The Revivent TC System for less invasive ventricular remodeling offers patients a treatment option for ischemic heart failure. We lead this trial in Europe as the Revivent TC system has the ability to address the underlying cause of heart failure in heart attack victims, the ventricle. The device can provide substantial volume reduction and exclusion of scar tissue to help remodel the ventricle to become more efficient."
Also commenting in the BioVentrix press release, Prof. Sebastian Kelle, MD, stated, "A critical parameter to survival for these types of patients is cardiac volume. We were able to see an immediate impact of around 40% volume reduction resulting in an 36% to 43% increase in ejection fraction for the patient that was treated in the REVIVE-HF trial. We have seen from our previous commercial experience in the last two years that these types of numbers have significantly changed the quality of life of patients who suffer from ischemic left ventricular dysfunction. We are proud to be the first center to enroll in this study." Prof. Kelle is a cardiologist at Deutsches Herzzentrum Berlin.