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

December 15, 2021 updated by: Antonio Rapacciuolo, Federico II University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

REACTION is an observational study in which patients will be followed as for clinical practice and no specific study tests/procedures will be perfprmed. After implanting a device, the patient will be assigned to an arm or to the other based on the technology of the device (bluetooth or RF) he/she wears, if he/she gives the consent to partecipate. It is not a randomized study. Patients will be enrolled consecutively until reaching the sample defined for both the arms.

Study Type

Observational

Enrollment (Anticipated)

1104

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
      • Naples, Italy, 80128

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
APP group
Patient wearing ICD with Bluetooth® technology and smartphone APP based remote monitoring
Device: smartphone APP based remote monitoring
smartphone APP to monitor remotely patients implanted with ICD
Bedside transmitter group
Patient wearing ICD monitored remotely through a bedside transmitter
Device: bedside transmitter based remote monitoring
bedside transmitter to monitor remotely patients implanted with ICD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 12 months

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
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical benefits in CRT area:
Time Frame: 12 Months
Association between patient symptom-triggered transmissions and HF events or other clinical events detected by device diagnostics
12 Months
Clinical benefits in ICD therapies
Time Frame: 12 months
Clinical action taken as a result of appropriate or inappropriate ICD therapies
12 months

Collaborators and Investigators

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

Sponsor

Federico II University

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)

September 22, 2021

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

April 1, 2025

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (ACTUAL)

January 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137/21

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.

Clinical Trials on Heart Failure

Clinical Trials on smartphone APP based remote monitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe