Study Design for REVIVE-HF: RCT in Europe

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The Revivent TC™ System has continued to deliver impressive results when evaluating post-market data in Europe.  The last 35 consecutive cases have resulted in a 34% improvement in ejection fraction (EF), 37% left ventricular volume reduction, zero deaths, and zero complications.  BioVentrix, Inc. announced today the study design for their Randomized Evaluation and Verification of Ventricular Enhancement or REVIVE-HF study to further investigate the Revivent TC System.  The trial design is based on feedback provided by the company’s Medical Advisory Board.  REVIVE-HF will investigate the efficacy of the Revivent TC System compared to Guideline Directed Medical Therapy (GDMT) for patients with left ventricular dysfunction resulting in heart failure.

REVIVE-HF is designed as a prospective, multi-center, dual-arm randomized controlled study comparing the treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus GDMT compared to GDMT alone.  This study will include 180 patients of which 120 patients will be treated with the Revivent TC System, and 60 patients will be maintained on GDMT. Its primary endpoint is improvement in heart failure symptoms based on a 6 Minute Walking Test. The Revivent TC System is intended for use in patients who have had a myocardial infarction (MI) (heart attack), 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 prognosis for patients with heart failure, low LVEF and ischemic, dilated left ventricles is very poor and the Revivent TC System offers a realistic solution to restore the heart,” says Professor Stefan Anker, REVIVE-HF Principal Investigator. “It is critical that ventricular restoration gets more attention again, especially with the advent of this less invasive approach, and the REVIVE-HF study will provide the evidence we need for ischemic heart failure patients with reduced ejection fraction.”

BioVentrix is a privately held medical device company headquartered in San Ramon, CA, USA. Our mission is to improve and expand the treatment available for congestive heart failure (CHF) caused by ischemic cardiomyopathy, through the development of less invasive, catheter-based approaches.

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