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NCT Number: NCT06311149

Multicenter Evaluation of Patients Using LATITUDE Monitoring System

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.

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Key information

Conditions

Cardiovascular Diseases Arrhythmias, Cardiac Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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.

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 10 years

    Mortality

Secondary outcomes

  1. Hospitalization

    Time frame: 10 years

    Hospitalization

  2. Device therapy

    Time frame: 10 years

    For therapeutic devices, e.g. ICDs, CRT-Ds, S-ICDs)

  3. Device-related complications

    Time frame: 10 years

    Complication

Study contacts

Contact information is provided by the study sponsor or research team.

Matteo Bertini, Prof

CONTACT

[email protected]

+390532236111

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

Multicenter Evaluation of Patients Using LATITUDE Monitoring System: Multitude Study

Acronym: Multitude

Important dates

Study start
2023
Primary completion
2043
Study completion
2043
First posted
Mar 15, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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