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MIRACLE EF evaluates CRT-P efficacy

Patient enrolment has begun in the MIRACLE EF trial, which will evaluate the effectiveness of cardiac resynchronisation therapy-pacemakers (CRT-Ps) in delaying the progression of heart failure in symptomatic patients with mildly reduced heart pumping function.

The study will evaluate CRT-P in those who have a slightly reduced left ventricular ejection fraction (LVEF) in the range of 36 to 50%. The CRT-P devices used in MIRACLE EF (Consulta,® Medtronic) are not currently approved by the USA Food and Drug Administration for the patient population being studied. Dr Edward Schloss performed the first implant at the Christ Hospital’s Lindner Research Center (Cincinnati, USA).

“Previous studies have proven the real-world therapeutic benefits of CRT in treating mildly to severely symptomatic heart failure patients with moderately- to severely-reduced cardiac pumping capacity and electrical dyssynchrony,” said principal investigator Professor Cecilia Linde (Karolinska University Hospital, Stockholm).

“Through this large global study we hope to further our research on the overall effectiveness of CRT-P by showing its benefit in treating patients with mild-to-moderate heart failure symptoms, but with milder impairment of heart pumping capacity than previously studied”.

SV_ MIRACLE-EF trial

Professor Cecilia Linde

Approximately 275 centres throughout the world, in regions including the United States, Canada, Europe, and Japan, will enrol up to 2,300 patients in the trial. Patients will be followed for at least two years or until the study closes. Medtronic anticipates the trial will take four to five years to complete. The effectiveness of CRT-P in this patient population will be assessed using a composite endpoint of time to first event, defined as all-cause mortality or heart failure hospitalisation.

Professor Linde spoke to BJC Arrhythmia Watch on the study’s key findings:All CRT studies so far have focused on heart failure patients with LVEFs either <30 or 35% and that is also the guidelines recommendation. In the studies, however, the LVEF of included patients has been lower than the inclusion criteria, generally around 22–25%”.

“But in the REVERSE (REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction) study that included LVEF up to 40%, we could observe that clinical benefit was present even in patients with an LVEF of 30–40%,” she continued.

“The main purpose of MIRACLE EF study is to assess if heart failure patients (NYHA II-III) with left bundle branch block with moderately to mildly reduced left ventricular function (but with higher LVEFs than previously studied, LVEF 36–50%) will benefit from CRT with regard to mortality and heart failure hospitalisations. If the study is positive it will mean that more patients with heart failure and reduced LVEF will be accessible to CRT than today,” she added.

Published on: January 25, 2013

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