US-based medical device company BioVentrix has enrolled and treated the first patient in its REVIVE-HF European study of Revivent TC System for the treatment of ischemic cardiomyopathy induced heart failure (HF).
BioVentrix said that the European multi-centre, dual-arm randomised controlled study REVIVE-HF is designed to evaluate the treatment of ischemic cardiomyopathy induced heart failure using its Revivent TCTM System, compared with the Guideline-Directed Medical Therapy (GDMT) or drug treatment.
REVIVE-HF principal investigator Volkmar Falk said: “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.”
The first patient for the study was enrolled and treated at Deutsches Herzzentrum Berlin (DHZB), Germany. The patient has developed ischemic heart failure and scarring in the left ventricle, due to a heart attack, and was implanted with three anchor pairs, as part of the treatment.
The Revivent TC System deploys anchoring technology to less invasively exclude scar
BioVentrix said that its Revivent TC System provides patients with the benefits of reducing the enlarged heart by less invasively excluding scar from the healthy tissue on the left ventricle with its anchoring technology.
In addition, its Revivent TC System is advised for patients with a myocardial infarction (heart attack), which creates a left ventricular scar that results in enlarged left ventricle, and causes heart failure symptoms, including fatigue, shortness of breath and/or physical limitations despite ongoing treatment.
The REVIVE-HF study is intended to enrol 180 patients, where 120 patients are planned to be treated with the Revivent TC System and 60 patients would be maintained on GDMT. Improvement in heart failure symptoms based on a 6 Minute Walking Test, is the primary endpoint of the study.
The company said that the enrolment is expected to validate the Revivent TC TransCatheter Ventricular Enhancement System as treatment option for ischemic heart failure with reduced ejection fraction (HFrEF) patients.
Cardiologist from DHZB Sebastian Kelle said: “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.”
