Clinical Research Directory

MIRAMACS, Multicenter Italian Study on RAdial Mechanically Assisted Circulatory Support

Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Summary

The Multicenter Italian Study on Radial Mechanically Assisted Circulatory Support (MIRAMACS) is an independent, non-sponsored, nationwide observational study designed to evaluate the clinical outcomes and device performance of continuous-flow ventricular assist devices (VAD), including both second and third-generation axial and centrifugal pumps, in the adult population. Coordinated by the Cardiac Surgery Department at the IRCCS Sant'Orsola Polyclinic in Bologna, the study aims to establish a comprehensive multicenter collaboration involving the majority of Italian reference centers for advanced heart failure. The primary objective is to assess patient survival at multiple time points, specifically focusing on in-hospital mortality and survival rates at one and five years post-implantation. Secondary objectives encompass a wide range of clinical and surgical metrics, including the duration of hospitalization, intensive care unit stay, and mechanical ventilation. The study will also rigorously monitor the incidence of adverse events such as right ventricular failure (with or without the need for temporary mechanical support), bleeding, thromboembolic episodes, systemic organ dysfunction, and the requirement for renal replacement therapy. Furthermore, the research will evaluate major neurological events, infections, pump-related complications including thrombosis or mechanical dysfunction, and longitudinal outcomes such as bridge-to-transplant (BTT) rates or bridge-to-recovery (BTR) myocardial improvement. The study population includes adult patients with advanced heart failure refractory to maximal medical therapy who have undergone implantation of continuous-flow VAD or BVAD systems. Exclusion criteria are limited to patients receiving pulsatile paracorporeal devices or total artificial hearts. MIRAMACS utilizes a mixed retrospective and prospective design, analyzing data from January 2010 onwards, with an estimated cohort exceeding 400 cases. Data collection is structured through the REDCap platform to ensure standardized national reporting, covering pre-operative diagnostics, surgical details, post-operative course, and long-term follow-up. Patient privacy is maintained through pseudonimization, where individual codes are known only to the local principal investigators. The study protocol is subject to approval by the Ethics Committee of the promoting center and the local ethics committees of all participating institutions, ensuring compliance with clinical research standards while offering patients the right to withdraw at any time without affecting their standard of care.

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