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RECRUITINGOBSERVATIONAL

Multicenter Evaluation of Patients Using LATITUDE Monitoring System

Multicenter Evaluation of Patients Using LATITUDE Monitoring System: Multitude Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Subject is willing and capable of providing willing to sign a consent form 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Locations (3)

Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Italy
Policlinico Federico II
Naples, Italy
Ospedale "G.B. Grassi"
Roma, Italy