ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12621001275853

Ethics application status

Approved

Date submitted

23/07/2021

Date registered

21/09/2021

Date last updated

21/09/2021

Date data sharing statement initially provided

21/09/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

I-TREAT: Intensive Follow-up via Remote Monitoring for Implantable Cardiac Devices

Scientific title

I-TREAT: Intensive Follow-up via Remote Monitoring for Implantable Cardiac Devices

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

I-TREAT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Heart arrythmias

Heart rhythm disorder

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Intensive Remote Monitoring
Intensive remote monitoring will occur via a cloud-based, automated, vendor-neutral software system with round-the-clock immediate processing of device alerts and scheduled downloads by trained technicians. Processed device data will be rapidly forwarded to the Cardiovascular Centre. The Cardiovascular Centre will access processed data, triaged alerts, and updated patient charts via a single, secure internet-based interface including all device vendors. Data collected though the cloud-base system includes all device and patient specific information, including time of alert, time at review, type of alert, time spent per alert response and actionable vs. non-actionable alerts.

The standard of care group will consist of 70 patients, randomly selected from the large cohort of patients who receive standard monitoring. Participants for the intervention group will be matched by age, gender and device type to the 70 patients in the standard care group.

There is no active participant involvement. Scheduled downloads occur every 6 months. Participants were followed up for 9 months, beginning September 2020. Information regarding subsequent interventions performed will not be collected.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

Standard Remote Monitoring (RM)
Clinic staff will access RM data via individual device vendor internet-based interfaces as per standard practice which includes daily alert checks, scheduled downloads and contacting patients regarding transmissions or clinical action. Response to RM data transmissions will be at the discretion of the investigator.

Devices for this group will be derived from the Cardiovascular Centre home monitoring cohort and matched as close as possible by device type and age to the devices in the intensive RM group.

Control group

Active

Outcomes

Primary outcome [1]

Time from event until intervention in case of actionable alert measured using data on transmission date and time, time to action and time to closing event which will be provided from the cloud-based system.

Timepoint [1]

9 months post enrolment

Secondary outcome [1]

Time from alert to review assessed using timestamp data

Timepoint [1]

9 months post enrolment

Secondary outcome [2]

Technician time spent per alert review assessed using timestamp data

Timepoint [2]

9 months post enrolment

Secondary outcome [3]

Technician time spend per alert response (contacting patient, treating clinician etc) assessed using timestamp data

Timepoint [3]

9 months post enrolment

Secondary outcome [4]

Proportion of alerts not requiring technician review after PaceMate alert adjudication will be assessed by audit of cloud-based system.

Timepoint [4]

9 months post enrolment

Eligibility

Key inclusion criteria

This study will enrol devices across different brands including Biotronik, Boston Scientific, Medtronic and Abbott.

The only inclusion criteria is the device is on PaceMate (vendor neutral remote monitoring system).

The standard of care group will consist of 70 patients, randomly selected from the large cohort of patients who receive standard monitoring. Participants will be matched by age, gender and device type to those patients in the intensive remote-monitoring group.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Sorin devices on home monitoring as they are not on PaceMate

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Case control

Timing

Prospective

Statistical methods / analysis

Descriptive analysis will be undertaken, with time to event will be assessed. Statistical analysis will be performed with SPSS version 24.0 (SPSS, Inc., Chicago, IL, USA). Categorical variables are represented as frequencies and percentages. Continuous variables are summarized as mean ± SD. For categorical variables, differences between groups will be compared between groups using a Chi-squared test. Continuous variables were compared by way of an independent t-test. A p-value of p<0.05 was considered statistically significant.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

20/08/2020

Date of last participant enrolment

Anticipated

Actual

20/09/2020

Date of last data collection

Anticipated

Actual

20/06/2021

Sample size

Target

140

Accrual to date

Final

140

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Adelaide

Address [1]

North Terrace, Adelaide SA 5000

Country [1]

Australia

Primary sponsor type

University

Name

Centre for Heart Rhythm Disorders, University of Adelaide

Address

Royal Adelaide Hospital, Cardiology 4G751-769, The University of Adelaide, Port Rd, Adelaide SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Health Network HREC

Ethics committee address [1]

Royal Adelaide Hospital
Port Road, Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/06/2020

Approval date [1]

10/08/2020

Ethics approval number [1]

Summary

Brief summary

Remote monitoring (RM) has been established as advantageous in the follow-up of patients with implantable cardiac devices as a safe alternative to standard clinic follow-up. While RM is associated with various benefits, compliance is often sub optimal suggesting a more intensive model of RM is required. 

The aim of the current trial is to determine the clinical utility, feasibility and workflow of implementing an intensive RM program compared to standard RM in patients with implantable cardiac devices.

We hypothesize that time from event to action will be shorter for patients in the intensive remote monitoring program compared to participants in the standard remote monitoring program.

Trial website

Trial related presentations / publications

Public notes

Recruitment will occur at the Cardiovascular Centre, a private Cardiologist Clinic. No recruitment will occur through hospitals.

Contacts

Principal investigator

Name

Dr Melissa Middeldorp

Address

Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide SA 5000
AUSTRALIA

Country

Australia

Phone

+61 08 8313 9019

Fax

melissa.middeldorp@adelaide.edu.au

Contact person for public queries

Name

Melissa Middeldorp

Address

Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide SA 5000
AUSTRALIA

Country

Australia

Phone

+61 08 8313 9000

Fax

melissa.middeldorp@adelaide.edu.au

Contact person for scientific queries

Name

Melissa Middeldorp

Address

Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide SA 5000
AUSTRALIA

Country

Australia

Phone

+61 08 8313 9000

Fax

melissa.middeldorp@adelaide.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Impact of intensive follow-up of cardiac implantable electronic devices via remote monitoring: A pilot study.	2023	https://dx.doi.org/10.1016/j.hroo.2022.11.002

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically