BioVentrix has announced the initiation of a phase II clinical trial to evaluate the safety and efficacy of its Revivent Myocardial Anchoring System for use in Less Invasive Ventricular Enhancement (LIVE) procedures in patients with heart failure. The phase II study commenced in Western Europe under the guidance of Louis Labrousse, professor of Cardiovascular Surgery, Hopital Haut-Leveque, Bordeaux-Pessac, France.
“The results from our first LIVE procedure using the Revivent Myocardial Anchoring System on a 58-year-old male with symptomatic heart failure confirm the safety and efficacy of this novel technique,” said Labrousse. “The left ventricle end diastolic volume decreased by 45% and the left ventricle end systolic volume decreased by 53%, while ejection fraction improved from 26% to 36%.
“Because this procedure was performed on a beating heart without the risks of a ventriculotomy or the need for cardiopulmonary bypass, the recovery of the patient is significantly faster. Our patient was released from the intensive care unit within two days of the LIVE procedure and released from the hospital within 10 days of undergoing treatment due to the excellent progress in recovery. Additionally, this was the first BioVentrix patient to be treated with an indwelling implantable cardioverter defibrillator. This further demonstrates that the Revivent technology can be applied to a broad spectrum of heart failure patients in various stages of treatment,” continued Labrousse.
The phase II, 50-patient study will take place at up to 25 institutions throughout the European Union, and will be limited to patients whose heart failure is due to ischaemic cardiomyopathy. The primary safety endpoint will be an assessment of the overall rate of serious adverse events during a 12-month follow-up period, and the primary efficacy endpoint will be assessment of a measurable decrease in left ventricle volume by either an echocardiogram or a cardiac magnetic resonance exam at six months, and at one year.
“BioVentrix has clinically proven the benefits of LIVE using the Revivent system as evidenced by improved clinical outcomes from patients treated to date,” said Tessa Yamut, vice president of regulatory and clinical affairs at BioVentrix. “In fact, data to be released later this month demonstrate that 12-month outcome measures show a clear trend in quality of life improvement from pre-operative evaluation.
“Our phase II study provides us the opportunity to broaden our clinical experience base amongst leading heart failure institutions throughout the European Union, as well as expand awareness of our promising, innovative technique,” said Yamut.
Earlier this year, BioVentrix presented six-month results of a phase I trial demonstrating safety and feasibility of the Revivent system for use in LIVE procedures. Results from the 26-patient trial indicate that the BioVentrix approach is an impactful method of treating ischaemic heart failure. Left ventricle volume reduction was accomplished in all 26 patients. Post-procedure follow-up included serial echocardiograms to measure the function of the left ventricle, six-minute walk tests, New York Heart Association (NYHA) functional class assessment, and quality of life questionnaires at one, three, six and 12 months.