Multicenter Evaluation of Patients Using LATITUDE Monitoring System (Multitude)

August 8, 2024 updated by: University Hospital of Ferrara

Multicenter Evaluation of Patients Using LATITUDE Monitoring System: Multitude Study

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ferrara, Italy, 44124
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Ferrara
        • Contact:
      • Napoli, Italy
      • Roma, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 10 years
Mortality
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization
Time Frame: 10 years
Hospitalization
10 years
Device therapy
Time Frame: 10 years
For therapeutic devices, e.g. ICDs, CRT-Ds, S-ICDs)
10 years
Device-related complications
Time Frame: 10 years
Complication
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Investigators

  • Principal Investigator: Matteo Bertini, Prof, Azienda Ospedaliera Universitaria di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 31, 2043

Study Completion (Estimated)

December 31, 2043

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 479/2023/Oss/AOUFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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