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

• Sponsor: Federico II University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05175937
• Collaborator: (none)
• Enrollment: 1,104
• Location: 1
• Anticipated Duration (Months): 42.3
• Patients Per Site Per Month: 26.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrhythmias; Sudden Cardiac Death; Heart Failure	Device: smartphone APP based remote monitoring; Device: bedside transmitter based remote monitoring

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 Design

• Study Type: Observational
• Anticipated Enrollment: 1104 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology
• Actual Study Start Date: Sep 22, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Adherence [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

2. Effectiveness [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

Secondary Outcome Measures

1. Clinical benefits in CRT area: [12 Months]

   Association between patient symptom-triggered transmissions and HF events or other clinical events detected by device diagnostics

2. Clinical benefits in ICD therapies [12 months]

   Clinical action taken as a result of appropriate or inappropriate ICD therapies

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prof Antonio Rapacciuolo,MD, PhD	Naples		Italy	80128

Sponsors and Collaborators

• Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antonio Rapacciuolo, Principal Investigator, Federico II University
• ClinicalTrials.gov Identifier: NCT05175937
• Other Study ID Numbers: 137/21
• First Posted: Jan 4, 2022
• Last Update Posted: Jan 4, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Antonio Rapacciuolo, Principal Investigator, Federico II University: Connectivity; Remote monitoring; Cardiac Implantable Electronic Device
• Additional relevant MeSH terms: Arrhythmias, Cardiac; Death, Sudden, Cardiac; Death

Study Results

No Results Posted as of Jan 4, 2022