Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Failure, Sudden Cardiac Death
Conditions
Keywords
Cardiac implantable electrical device, Implantable cardioverter defibrillator, Pacemaker, Cardiac resynchronization therapy, Subcutaneous defibrillator, Implantable cardiac monitor, Remote monitoring, Latitude monitoring system
Brief summary
The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database. The registry is designed to constitute a shared environment for the collection, management, analysis and reporting of clinical and diagnostic data, adopted by a network of European scientifically-motivated physicians who use rhythm management diagnostic and therapeutic solutions from Boston Scientific in their clinical practice. The Multitude study will facilitate the sharing of scientific proposals within a large network of researchers, and it will allow researchers to record the experience with medical devices throughout the device and patient lifecycle.
Interventions
None listed
Sponsors
University Hospital of Ferrara
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subject is willing and capable of providing informed consent to collect/store/process personal health information by the sponsor or such consent is provided by a legally designated representative, if required by local law or regulation. * Subject is: 1. prospectively scheduled for receiving a device monitored through the LATITUDE monitoring system 2. retrospectively enrolled after having received a device monitored through the LATITUDE monitoring system
Exclusion criteria
* Subject foreseen not to be followed at the enrolling center for at least 1 year after having received the device. * Subject is receiving a device that is not approved for commercial use at the time of procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 10 years | Mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization | 10 years | Hospitalization |
| Device therapy | 10 years | For therapeutic devices, e.g. ICDs, CRT-Ds, S-ICDs) |
| Device-related complications | 10 years | Complication |
Countries
Italy
Contacts
Primary ContactMatteo Bertini, Prof
Outcome results
None listed