Cardiac ArrhythmiasREACTIONNCT05175937
REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology
An observational study of Cardiac Arrhythmias and Sudden Cardiac Death, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias, Sudden Cardiac Death, Heart Failure
- What is being tested?
- smartphone APP based remote monitoring and bedside transmitter based remote monitoring
- Type of treatment
- Medical device
- How many people
- 1,104 participants
- Where
- 1 siteItaly
- Study dates
- 22 Sep 2021to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Subject who is, or is expected to be inaccessible for follow-up
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Prof Antonio Rapacciuolo,MD, PhD
Naples, 80128
Antonio Rapacciuolo, +393470660290, antonio.rapacciuolo@unina.it
About this study
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.
Read the 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.
- Conditions
- Cardiac Arrhythmias, Sudden Cardiac Death, Heart Failure
- Being tested
- smartphone APP based remote monitoring, bedside transmitter based remote monitoring
- Keywords
- Connectivity, Remote monitoring, Cardiac Implantable Electronic Device
- Medical subject headings
- Arrhythmias, Cardiac, Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphone APP based remote monitoringDevice
smartphone APP to monitor remotely patients implanted with ICD
bedside transmitter based remote monitoringDevice
bedside transmitter to monitor remotely patients implanted with ICD
| Study group | Role | What they receive |
|---|---|---|
| APP group | Patient wearing ICD with Bluetooth® technology and smartphone APP based remote monitoring Receives: Device: smartphone APP based remote monitoring | |
| Bedside transmitter group | Patient wearing ICD monitored remotely through a bedside transmitter Receives: Device: bedside transmitter based remote monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
The adherence will be measured through the following endpoints:
- Compliance with RM quantified as percentage of patients who registered with the smartphone App
Measured: 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
Measured: 12 months
Secondary outcomes (2)
Clinical benefits in CRT area:
Association between patient symptom-triggered transmissions and HF events or other clinical events detected by device diagnostics
Measured: 12 Months
Clinical benefits in ICD therapies
Clinical action taken as a result of appropriate or inappropriate ICD therapies
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start22 Sep 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Rapacciuolo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175937
- Sponsor's protocol ID
- 137/21
- Acronym
- REACTION
- Status last verified
- Dec 2021
- First submitted
- 18 Nov 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology
- ClinicalTrials.gov ID
- NCT05175937
- Acronym / sponsor ID
- REACTION / 137/21
- Conditions
- Cardiac Arrhythmias, Sudden Cardiac Death, Heart Failure
- Keywords
- Connectivity, Remote monitoring, Cardiac Implantable Electronic Device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,104 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APP group | – | Device: smartphone APP based remote monitoringPatient wearing ICD with Bluetooth® technology and smartphone APP based remote monitoring |
| Bedside transmitter group | – | Device: bedside transmitter based remote monitoringPatient wearing ICD monitored remotely through a bedside transmitter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Subject who is, or is expected to be inaccessible for follow-up
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smartphone APP based remote monitoringsmartphone APP to monitor remotely patients implanted with ICD | Device | APP group |
| bedside transmitter based remote monitoringbedside transmitter to monitor remotely patients implanted with ICD | Device | Bedside transmitter group |
Primary outcome
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
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
2 secondary outcomes
Clinical benefits in CRT area:
Time frame: 12 Months
Clinical benefits in ICD therapies
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias and Sudden Cardiac Death, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Rapacciuolo, MD, PhD (081-7461111, antonio.rapacciuolo@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.