Evaluation of patients using the LATITUDE monitoring system for heart devices
Multicenter Evaluation of Patients Using LATITUDE Monitoring System: Multitude Study
This study is testing how well the LATITUDE monitoring system works for patients with heart devices to help doctors share information and improve care across Europe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Sex | All |
| Sponsor | University Hospital of Ferrara Academic / other |
| Locations | 3 sites (Ferrara and 2 other locations) |
| Trial ID | NCT06311149 on ClinicalTrials.gov |
What this trial studies
This registry collects and analyzes data from patients who receive cardiac implantable electrical devices (CIEDs) that communicate remotely through the LATITUDE monitoring system. It aims to create a shared environment for physicians across Europe to manage and report clinical data related to these devices. The study will facilitate collaboration among researchers and document experiences with medical devices throughout their lifecycle, enhancing understanding of their effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates include patients who are scheduled to receive or have already received a LATITUDE-monitored cardiac device.
Not a fit: Patients who will not be followed at the enrolling center for at least one year after receiving the device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve patient outcomes by providing valuable insights into the management of cardiovascular diseases through advanced monitoring.
How similar studies have performed: Other studies utilizing remote monitoring systems for cardiac devices have shown promise, indicating that this approach is supported by prior successful research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ferrara and 2 other locations
- Azienda Ospedaliero-Universitaria di Ferrara — Ferrara, Italy (Recruiting)
- Policlinico Federico II — Naples, Italy (Recruiting)
- Ospedale "G.B. Grassi" — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Matteo Bertini, Prof — Azienda Ospedaliera Universitaria di Ferrara
- Study coordinator: Matteo Bertini, Prof
- Email: doc.matber@gmail.com
- Phone: +390532236111
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.