Multicenter Evaluation of Patients Using LATITUDE Monitoring System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital of Ferrara
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
prospectively scheduled for receiving a device monitored through the LATITUDE monitoring system
retrospectively enrolled after having received a device monitored through the LATITUDE monitoring system
Disqualifiers
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.
Trial population
The subjects will be recruited from the general patient population of the participating centers who are * receiving diagnosis or treatment using a device monitored through the LATITUDE monitoring system and * fulfilling all inclusion criteria and none of the exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Mortality
Mortality
Time frame
10 yearsSecondary outcomes
1
Hospitalization
Hospitalization
Time frame
10 years2
Device therapy
For therapeutic devices, e.g. ICDs, CRT-Ds, S-ICDs)
Time frame
10 years3
Device-related complications
Complication
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov