MIRAMACS, Multicenter Italian Study on RAdial Mechanically Assisted Circulatory Support
MIRAMACS
1 other identifier
observational
400
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2025
CompletedFirst Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
May 20, 2026
May 1, 2026
4 years
March 4, 2026
May 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
In-hospital survival, 1-year and 5-year survival after VAD implantation
In-hospital survival, 1-year and 5-year survival after VAD implantation
5 years after VAD implantation
Eligibility Criteria
Patients with advanced heart failure refractory to maximal medical therapy, and therefore undergoing continuous-flow (centrifugal/radial) VAD implantation, will be recruited
You may qualify if:
- Patients with advanced heart failure refractory to maximal medical therapy, and therefore undergoing implantation of continuous-flow (radial) VAD devices, will be recruited
- Only the adult population will be included
- Continuous-flow implantable BIVAD systems are also included.
You may not qualify if:
- Mechanical devices other than those specified
- Paracorporeal pulsatile devices and total artificial heart (TAH).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Ospedale di Bergamo, ASST Papa Giovanni XXIII, Bergamo
Bergamo, Bergamo, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138, Italy
Ospedale Policlinico San Martino
Genova, Genova, Italy
I.R.C.C.S. Ospedale San Raffaele Milano
Milan, Milano, Italy
Ospedale Niguarda, Milano
Milan, Milano, Italy
Azienda Ospedale Università Padova
Padova, Padova, Italy
ISMETT, Istituto di Ricovero e Cura a Carattere Scientifico
Palermo, Palermo, Italy
Policlinico San Matteo Pavia Fondazione IRCCS
Pavia, Pavia, Italy
Azienda Ospedaliera San Camillo Forlanini di Roma
Roma, Roma, Italy
Azienda Ospedaliero-Universitaria Senese
Siena, Siena, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Torino, Italy
Azienda Sanitaria Universitaria integrata di Udine
Udine, Udine, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Verona, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 9, 2026
Study Start
January 10, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
May 20, 2026
Record last verified: 2026-05