Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000228583p
Ethics application status
Submitted, not yet approved
Date submitted
29/10/2023
Date registered
7/03/2024
Date last updated
7/03/2024
Date data sharing statement initially provided
7/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
EPIC-RM: Evaluating the clinical safety and cost-effectiveness of Exception-based Patient care Cardiac Implantable Electronic Devices (CIED) Remote Monitoring
Scientific title
EPIC-RM: Evaluating the clinical safety and cost-effectiveness of Exception-based Patient care Cardiac Implantable Electronic Devices (CIED) Remote Monitoring
Secondary ID [1] 307761 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Implantable 331889 0
Condition category
Condition code
Public Health 328619 328619 0 0
Health service research
Cardiovascular 328620 328620 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a phase 3, multi-centre, open-label, prospective, parallel arm, randomised controlled trial in CIED patients. These patients with CIEDs include those with permanent pacemakers (PPMs) and implantable cardioverter defibrillators (ICDs). We will compare remote monitoring of CIEDs in conjunction with standard care, versus standard care alone. In addition to the required study arm, we will evaluate an Exception-Based Care Remote Monitoring (EBC-RM) model for CIED patients over 4 years. We will include the composite of safety events to assess the relative clinical safety and cost impact of each of the comparator strategies, with participants followed up for a minimum of 24 months.

Three arms of the trial:
a) Exception-based care remote monitoring:
Participants allocated to EBC- based RM will receive an in-office check at weeks 1- 6 to check wound healing in the case of PPM or ICD implants according to local procedures and establish remote monitoring (participants with recent CIEDs only). Participants would undergo remote monitoring using the standard profile of their specific device, with scheduled transmissions at 6-monthly intervals. Participants would receive communication from the remote monitoring team (i.e. consultant, cardiologist, electrophysiology fellow, cardiology advanced trainee, nurse or allied health practitioner involved in CIED care), at their local institution via text message or letter, 6-monthly. Participants in this arm would undergo any routine care from their cardiologist as they would require for any prior cardiac conditions, but not have a scheduled device check as part of this care. If participants experienced device-detected adverse findings related to CIED function or health status change (e.g., detection of AF via remote monitoring), participants would be called into clinic for appropriate clinical management. For participants already followed up by a cardiologist, written advice updating their treating cardiologist with recommendations for changes to clinical management would be provided.

CIED technology allow interrogation and transmissions of data stored in these devices wirelessly i.e., device function, cardiovascular events, and patient clinical status. All data is continuously saved within the device memory. During device interrogation, telemetry is used to retrieve information on the CIED programmed parameters and data stored in the CIED memory. During remote monitoring, a device designed to receive telemetry from a specific CIED will transmit encrypted data using telephone technology to a remote-secure monitoring centre/server (i.e., your local hospital or clinic). Often the home monitor or communicator is stationary and connected to the internet through an analogue telephone line in the patient’s home, but it can also be a portable unit.

b) Remote monitoring plus scheduled in-office follow-up:
Participants allocated to remote monitoring plus scheduled in-office follow-up would be managed as above but would also have a scheduled 6-monthly office follow-up (in the case of ICDs), or 12-monthly follow-up (in the case of PPMs). The scheduled in-office follow-up would be performed as per local protocols, by cardiologists, cardiac physiologists or CIED care nurses. Participants in this group would remain eligible to be called for unscheduled clinic appointments as required to deal with device-detected adverse findings, related to CIED function or health status change, as above.

All participants, across all three arms (including comparator arm) will be followed up according to local clinical protocols should they experience unscheduled device related changes to their health status as part of study outcomes. Furthermore, adherence to trial will be monitored by communication from the study team. The study team will communicate upcoming remote monitoring, and/or office-based check up dates and requirements (i.e. questionnaire completion) with participants at appropriate intervals.
Intervention code [1] 327270 0
Treatment: Devices
Intervention code [2] 327728 0
Treatment: Other
Comparator / control treatment

c) Scheduled in-office follow-up only:
Participants allocated to scheduled in-office follow-up only would not be remotely monitored. They would receive office follow-up by cardiologists, cardiac physiologists or CIED nurses as per local clinical protocol.

The control group in this trial will receive office-based follow-ups by cardiologists, cardiac physiologists or CIED nurses as per local clinical protocol. This is also defined as standard care and will not be remotely monitored and the control group is the same office-based follow up arm.
Control group
Active

Outcomes
Primary outcome [1] 336421 0
The composite of cardiovascular death and unplanned cardiovascular hospitalisation. Study team will assess these by accessing electronic medical records.
Timepoint [1] 336421 0
From baseline/randomisation visit, week 1-6 (patients with new CIEDs only), 6 monthly (patients with ICDs), 12 monthly (patients with PPMs), and through to follow-up at 24 months (minimum).
Primary outcome [2] 337040 0
Number of device related clinic visits, including scheduled and unscheduled office visits. This outcome will be assessed by accessing electronic-medical records.
Timepoint [2] 337040 0
From baseline/randomisation visit, week 1-6 (patients with new CIEDs only), 6 monthly (patients with ICDs), 12 monthly (patients with PPMs), and through to follow-up at 24 months (minimum). These outcomes will also be assessed during any unscheduled visits (due to health status changes or CIED device-related findings of significance).
Secondary outcome [1] 428309 0
All cause and cardiovascular death - electronic medical records
Timepoint [1] 428309 0
From baseline/randomisation visit, week 1-6 (patients with new CIEDs only), 6 monthly (patients with ICDs), 12 monthly (patients with PPMs), and through to follow-up at 24 months (minimum).
Secondary outcome [2] 430453 0
Unplanned and planned all cause & cardiovascular hospitalisation - electronic medical records
Timepoint [2] 430453 0
From baseline/randomisation visit, week 1-6 (patients with new CIEDs only), 6 monthly (patients with ICDs), 12 monthly (patients with PPMs), and through to follow-up at 24 months (minimum). These outcomes will also be assessed during any unscheduled visits (due to health status changes or CIED device-related findings of significance).
*Please note that patients with new CIEDs will only require 1 visit between weeks 1-6 of implantation to ensure wound healing*
Secondary outcome [3] 430454 0
Scheduled visits related to CIED, those which resulted in change to programming - electronic medical records
Timepoint [3] 430454 0
From baseline/randomisation visit, week 1-6 (patients with new CIEDs only), 6 monthly (patients with ICDs), 12 monthly (patients with PPMs), and through to follow-up at 24 months (minimum). These outcomes will also be assessed during any unscheduled visits (due to health status changes or CIED device-related findings of significance).
*Please note that patients with new CIEDs will only require 1 visit between weeks 1-6 of implantation to ensure wound healing*
Secondary outcome [4] 430455 0
Unscheduled visits - electronic medical records
Timepoint [4] 430455 0
From baseline/randomisation visit, week 1-6 (patients with new CIEDs only), 6 monthly (patients with ICDs), 12 monthly (patients with PPMs), and through to follow-up at 24 months (minimum). These outcomes will also be assessed during any unscheduled visits (due to health status changes or CIED device-related findings of significance).
Secondary outcome [5] 430456 0
Health resource utilisation - Economic questions for EQ5D5L and cost impact economics questionnaires
Timepoint [5] 430456 0
From baseline/randomisation visit, week 1-6 (patients with new CIEDs only), 6 monthly (patients with ICDs), 12 monthly (patients with PPMs), and through to follow-up at 24 months (minimum). These outcomes will also be assessed during any unscheduled visits (due to health status changes or CIED device-related findings of significance).

Eligibility
Key inclusion criteria
Patients will be considered eligible to participate in the study if:
(i) aged 18 and over
(ii) written informed consent
(iii) willing to be randomised
(iv) have a Cardiac Implantable Electronic Device (CIED) or are scheduled to undergo CIED implantation

(No limitations on PPM or ICD manufacturer or follow-up platform will be designated, according to local preference).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they:
(i) Under the age of 18
(ii) have a life expectancy considered to be less than 12 months
(iii) are with CIED generators or leads where the manufacturer has recommended continuous RM

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is possible as it will done by central randomisation through RedCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated in REDCap. Stratified block randomisation will be used by device type (PPM or ICD) and region type (regional or metro), to ensure balance across regions and recruitment sites.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
414
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 312026 0
Government body
Name [1] 312026 0
Department of Health and Aged Care - MRFF grant funded study
Country [1] 312026 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 313527 0
None
Name [1] 313527 0
Address [1] 313527 0
Country [1] 313527 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311446 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 311446 0
Ethics committee country [1] 311446 0
Australia
Date submitted for ethics approval [1] 311446 0
27/10/2023
Approval date [1] 311446 0
Ethics approval number [1] 311446 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121122 0
Prof Anand Ganesan
Address 121122 0
Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia 5042
Country 121122 0
Australia
Phone 121122 0
+61 08 8204 5619
Fax 121122 0
Email 121122 0
anand.ganesan@flinders.edu.au
Contact person for public queries
Name 121123 0
Anand Ganesan
Address 121123 0
Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia 5042
Country 121123 0
Australia
Phone 121123 0
+61 08 8204 5619
Fax 121123 0
Email 121123 0
anand.ganesan@flinders.edu.au
Contact person for scientific queries
Name 121124 0
Anand Ganesan
Address 121124 0
Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia 5042
Country 121124 0
Australia
Phone 121124 0
+61 08 8204 5619
Fax 121124 0
Email 121124 0
anand.ganesan@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No additional documents have been identified.