Multicenter Evaluation of Patients Using LATITUDE Monitoring System

Recruiting

• Conditions: Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Sudden Cardiac Death

• Registration Number: NCT06311149
• Lead Sponsor: University Hospital of Ferrara

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-01
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-15
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12
• Primary Completion: 2043-12-31
• Study Completion: 2043-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	10 years	Mortality

Secondary Outcome Measures

Name	Time	Method
Device therapy	10 years	For therapeutic devices, e.g. ICDs, CRT-Ds, S-ICDs)
Device-related complications	10 years	Complication
Hospitalization	10 years	Hospitalization

Trial Locations

Locations (3)

Azienda Ospedaliero-Universitaria di Ferrara; 🇮🇹 Ferrara, Italy

Policlinico Federico II; 🇮🇹 Napoli, Italy

Ospedale "G.B. Grassi"; 🇮🇹 Roma, Italy