Italian registry of radial continuous-flow ventricular assist devices (MIRAMACS)
MIRAMACS, Multicenter Italian Study on RAdial Mechanically Assisted Circulatory Support
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07458074
This project will see how adults with advanced heart failure do after receiving continuous-flow radial ventricular assist devices (axial and centrifugal pumps).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT07458074 on ClinicalTrials.gov |
What this trial studies
MIRAMACS is an independent, nationwide observational registry coordinated by the Cardiac Surgery Department at IRCCS Sant'Orsola in Bologna that combines retrospective data from January 2010 with prospective enrollment across major Italian referral centers. The registry captures clinical outcomes and device performance for adult patients implanted with second- and third-generation radial continuous-flow VADs, including implantable BIVADs. The primary focus is on survival during hospitalization and at one and five years after implantation, while secondary outcomes include length of hospital and ICU stay, duration of mechanical ventilation, and incidence of device-related adverse events. Data are collected using a structured REDCap platform to standardize reporting and enable multicenter collaboration.
Who should consider this trial
Good fit: Adults with advanced heart failure refractory to maximal medical therapy who receive implantable continuous-flow radial VADs (including second- and third-generation axial or centrifugal pumps and implantable BIVADs) are the intended participants.
Not a fit: Children and patients treated with paracorporeal pulsatile devices, total artificial hearts, or other mechanical devices not specified in the protocol are unlikely to benefit from this registry's findings.
Why it matters
Potential benefit: If successful, the registry could give clinicians clearer, real-world information on long-term survival and device risks to help improve patient selection and post-implant care.
How similar studies have performed: Previous large registries and trials of continuous-flow ventricular assist devices have demonstrated improved survival and reduced complications compared with older technologies, although comprehensive nationwide registries focused specifically on radial systems are less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Mechanical devices other than those specified * Paracorporeal pulsatile devices and total artificial heart (TAH).
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Antonino Loforte, MD
- Email: Antonino.loforte@aosp.bo.it
- Phone: +3905121459043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure