NCT07458074

MIRAMACS, Multicenter Italian Study on RAdial Mechanically Assisted Circulatory Support

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Multicenter Italian Study on Radial Mechanically Assisted Circulatory Support, known by the acronym MIRAMACS, represents a comprehensive, independent, and non-sponsored clinical research initiative designed to evaluate the clinical performance and long-term outcomes of continuous-flow radial mechanical ventricular assist devices as a therapeutic strategy for patients suffering from advanced heart failure. This observational study, coordinated by the Cardiac Surgery Department of the IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola as the promoting scientific center, integrates both a retrospective analysis dating back to January 2010 and a prospective enrollment phase to capture a robust nationwide dataset from the primary Italian referral centers specializing in advanced heart failure and surgical circulatory support. The primary objective of the MIRAMACS registry is to provide an exhaustive description of patient survival rates and the incidence of adverse events associated with continuous-flow ventricular assist device therapy, focusing specifically on axial and centrifugal pumps categorized as second and third-generation radial systems. By establishing a structured data collection framework on the RedCap platform, the study aims to foster high-level scientific collaboration across the majority of national cardiac surgery centers, ensuring that data regarding pre-operative diagnostic workups, surgical implantation details, post-operative clinical courses, and long-term post-discharge follow-ups are standardized and shared on a national scale. The primary endpoints of the study are centered on survival metrics, specifically assessing in-hospital survival as well as survival rates at one year and five years following the implantation of the ventricular assist device. To provide a holistic view of the clinical impact of these devices, the study also monitors an extensive range of secondary objectives including the total duration of hospitalization, the length of stay in intensive care units, and the duration of mechanical ventilation required post-implantation. Furthermore, the registry meticulously tracks the frequency and severity of right ventricular failure, noting whether such cases necessitate temporary right ventricular mechanical support. Other critical secondary outcomes include the incidence of bleeding events, thromboembolic complications, systemic organ dysfunction, and the requirement for renal replacement therapy or dialysis due to acute kidney injury. The study also focuses on major neurological events, infectious complications, and device-specific issues such as pump thrombosis or mechanical pump dysfunction. In terms of longitudinal patient management, MIRAMACS evaluates the frequency of heart transplantation for patients on a Bridge to Transplant (BTT) pathway as well as cases of myocardial recovery leading to device explantation, known as Bridge to Recovery (BTR). A central theme of the research is the assessment of freedom from short-term, medium-term, and long-term device-related adverse events. The study population is strictly limited to adult patients who have been diagnosed with advanced heart failure refractory to maximal pharmacological therapy and have subsequently undergone the implantation of continuous-flow radial ventricular assist devices. The inclusion criteria extend to patients receiving continuous-flow biventricular assist systems (BVAD), while the exclusion criteria explicitly omit patients treated with mechanical devices other than those specified, such as pulsatile paracorporeal devices or total artificial hearts. Ethical integrity is a cornerstone of the MIRAMACS study, requiring all participants to provide informed consent after receiving detailed information from qualified clinical personnel. Participation is entirely voluntary, and patients retain the right to withdraw at any time without any impact on their standard of care or therapeutic pathway. To ensure data privacy and security, all collected information is pseudonymized using a unique reference code known only to the principal investigator at each participating site. While the study is promoted by the Sant'Orsola Polyclinic, it mandates formal approval from the local Ethics Committee of every participating center before data entry can commence. With an estimated enrollment exceeding 400 cases since 2010, MIRAMACS seeks to bridge the gap in national clinical evidence regarding the durability and efficacy of modern mechanical circulatory support, providing the Italian scientific community with a powerful tool to refine surgical techniques, optimize post-operative management, and ultimately improve the prognosis and quality of life for patients battling end-stage heart failure through the use of cutting-edge radial flow technology. The scientific and technical committee at the promoting center oversees the coordination of the national database, ensuring that the transition from retrospective data harvesting to prospective clinical monitoring remains seamless and methodologically sound across all contributing Italian institutions.

Conditions

• Heart Failure

Timeline

• Start date: 2025-01-10
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-03-09
• Last updated: 2026-03-12

Locations

1 site across 1 country: Italy