REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology

NCT05175937 | Unknown

• 1 other identifier: 137/21
• Study Type: observational
• Target: 1,104
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this observational study is to assess clinical benefits of innovative features (e.g. Bluetooth technology and smartphone patient applications) in a patient population that is implanted with standard indication for implantable cardiac defibrillator.

Conditions

Cardiac Arrhythmias; Sudden Cardiac Death; Heart Failure

Keywords

Connectivity; Remote monitoring; Cardiac Implantable Electronic Device

Outcome Measures

Primary Outcomes (2)

• Adherence

  The adherence will be measured through the following endpoints: • Compliance with RM quantified as percentage of patients who registered with the smartphone App

  12 months

• Effectiveness

  The effectiveness based on the comparison between the App monitoring and the traditional remote control will be assessed through the following endpoints: • Percentage of time (days) with an active connection between device and the transmitter/smartphone app

  12 months

Secondary Outcomes (2)

• Clinical benefits in CRT area:

  12 Months

• Clinical benefits in ICD therapies

  12 months

Study Arms (2)

APP group

Patient wearing ICD with Bluetooth® technology and smartphone APP based remote monitoring

Device: smartphone APP based remote monitoring

Bedside transmitter group

Patient wearing ICD monitored remotely through a bedside transmitter

Device: bedside transmitter based remote monitoring

Interventions

smartphone APP based remote monitoring DEVICE

smartphone APP to monitor remotely patients implanted with ICD

APP group

bedside transmitter based remote monitoring DEVICE

bedside transmitter to monitor remotely patients implanted with ICD

Bedside transmitter group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample size will be about 1104 patients; 736 patients implanted with Bluetooth technology devices and 368 patients followed with traditional remote control.

You may qualify if:

• All patients implanted with an ICD as for standard indications
• Over 18 years of age
• Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations

You may not qualify if:

• Subject who is, or is expected to be inaccessible for follow-up
• pregnancy

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Prof Antonio Rapacciuolo,MD, PhD

Naples, 80128, Italy

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Death, Sudden, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Central Study Contacts

Antonio Rapacciuolo, MD, PhD

CONTACT

081-7461111; antonio.rapacciuolo@unina.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: January 4, 2022
• Study Start: September 22, 2021
• Primary Completion: December 31, 2023
• Study Completion: April 1, 2025
• Last Updated: January 4, 2022

Record last verified: 2021-12

Locations

IT (1)