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

NCT ID: NCT05175937

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-22

Study Completion Date

2025-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Arrhythmias Sudden Cardiac Death Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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APP group

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

smartphone APP based remote monitoring

Intervention Type DEVICE

smartphone APP to monitor remotely patients implanted with ICD

Bedside transmitter group

Patient wearing ICD monitored remotely through a bedside transmitter

bedside transmitter based remote monitoring

Intervention Type DEVICE

bedside transmitter to monitor remotely patients implanted with ICD

Interventions

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smartphone APP based remote monitoring

smartphone APP to monitor remotely patients implanted with ICD

Intervention Type DEVICE

bedside transmitter based remote monitoring

bedside transmitter to monitor remotely patients implanted with ICD

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Antonio Rapacciuolo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prof Antonio Rapacciuolo,MD, PhD

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio Rapacciuolo, MD, PhD

Role: CONTACT

081-7461111

Facility Contacts

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Antonio Rapacciuolo

Role: primary

+393470660290

Other Identifiers

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137/21

Identifier Type: -

Identifier Source: org_study_id

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