Italian registry of radial continuous-flow ventricular assist devices (MIRAMACS)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Bologna, Italy Recruiting
• Ospedale di Bergamo, ASST Papa Giovanni XXIII, Bergamo
  Bergamo, Bergamo, Italy Not yet recruiting
• Ospedale Policlinico San Martino
  Genova, Genova, Italy Not yet recruiting
• I.R.C.C.S. Ospedale San Raffaele Milano
  Milan, Milano, Italy Not yet recruiting
• Ospedale Niguarda, Milano
  Milan, Milano, Italy Not yet recruiting
• Azienda Ospedale Università Padova
  Padova, Padova, Italy Not yet recruiting

Study contacts

• Study coordinator: Luca Botta, MD
• Email: luca.botta@aosp.bo.it
• Phone: +3905121459043

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.