Multicenter Evaluation of Patients Using LATITUDE Monitoring System (Multitude)

University Hospital of Ferrara

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06311149

479/2023/Oss/AOUFe

Details and patient eligibility

About

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.

Enrollment: 20,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.