Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000659909
Ethics application status
Approved
Date submitted
3/04/2020
Date registered
9/06/2020
Date last updated
9/06/2020
Date data sharing statement initially provided
9/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Burden of Remote Monitoring Alerts in Patients with a Cardiac Implantable Electronic Device
Scientific title
Burden of Remote Monitoring Alerts in Patients with a Cardiac Implantable Electronic Device
Secondary ID [1] 300941 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Permanent Pacemaker 316941 0
Implantable Cardioverter Defibrillator 316942 0
Implantable Loop Recorder 316943 0
Cardiac Arrhythmias 316944 0
Condition category
Condition code
Cardiovascular 315103 315103 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
Remote monitoring (RM), also known as home monitoring, of patients with cardiac implantable electronic devices (CIEDs), is associated with various benefits including rapid clinical response to patient and device events, fewer in-person evaluations, and cost reductions. Further, various studies have identified a mortality benefit.

Though now considered the standard of care for the follow-up of all CIEDs, RM can be clinically onerous. Originally developed as a more intense, efficient and convenient substitute for the standard in-person clinic evaluation, RM has progressed to involve relatively frequent contact between devices and clinics, with some device manufacturers facilitating daily remote transmissions. As the CIED population expands, so does RM burden, with inevitably rising alert volumes. We seek to assess the RM transmission burden in a multicentre cohort via the use of an integrated software system.

This is a retrospective, observational study. We will undertake analysis of a large multi-centre cohort of patients who received RM during a twelve-month period using PaceMate LIVETM, a software system with automatic integration of all RM transmissions and alerts from multiple device vendors, streamlined into a single user interface. The cohort will consist of 26,713 consecutive patients who received remote monitoring from November 2018 to November 2019.

De-identified data will be provided from PaceMateTM, who provides a remote monitoring service for thousands of patients. The data will be derived from the PaceMate LIVE registry database. The data will include CIED type, CIED manufacturer, patient age, and any RM alerts transmitted to PaceMate LIVE.

All transmissions have been analysed upon receipt by cardiac technicians certified by the International Board of Heart Rhythm Examiners via a service that is available 24 hours a day, 7 days a week for immediate (where possible, depending on the burden of RM transmissions cued for analysis) analysis and processing of all RM transmissions and alerts.

Alerts have been categorised as either:
1. Red: high acuity requiring urgent clinical response;
2. Yellow: lesser acuity requiring non-urgent response; or
3. Green: Scheduled or patient-initiated transmissions that did not reach alert criteria.

As per PaceMate protocol, after alert analysis, a concise written alert summary was transmitted to patient’s relevant clinic, via the same streamlined user interface, obviating the need for clinic staff to re-analyse electrogram and electrocardiogram tracings. This allows immediate shelving of any transmission not requiring a clinical response. Programming of alerts (as yellow or red) was left to the discretion of the treating physician, as was the clinical response to actionable alerts.

The exposure is remote monitoring of patients with a cardiac implantable electronic device (permanent pacemaker, implantable cardioverter defibrillator, or implantable loop recorder). The exposure is not experimental but rather part of routine clinical practice in the care of this patient population.

The observational period for this study is 12 months, however these patients are already receiving routine remote monitoring.
Intervention code [1] 317255 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323388 0
The total number of remote monitoring alerts transmitted via the remote monitoring system, from each of the 3 patient device groups (permanent pacemaker, implantable cardioverter defibrillator, implantable loop recorder,) at the end of a 12-month monitoring period.
Timepoint [1] 323388 0
12 months
Secondary outcome [1] 381777 0
The number of red alerts (high acuity) transmitted via the remote monitoring system, from each of the 3 device groups (permanent pacemaker, implantable cardioverter defibrillator, implantable loop recorder), at the end of a 12-month monitoring period.
Timepoint [1] 381777 0
12 months
Secondary outcome [2] 382288 0
The number of yellow alerts (lower acuity) transmitted via the remote monitoring system, from each of the 3 device groups (permanent pacemaker, implantable cardioverter defibrillator, implantable loop recorder), at the end of a 12-month monitoring period.
Timepoint [2] 382288 0
12 months

Eligibility
Key inclusion criteria
Any patient currently receiving remote monitoring via our remote monitoring system, PaceMate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
No specific sample size required; the number of patients studied will be determined by how many patients are currently receiving our remote monitoring service.
Descriptive statistics will be undertaken via SPSS (version 26). Categorical variables will be expressed as a percentage and compared via the exact Pearson’s X2 test. A two-sided p value of less than 0.05 will be considered statistically significant. Continuous variables will be expressed as mean +/- standard deviation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/06/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26713
Accrual to date
Final
Recruitment outside Australia
Country [1] 22466 0
United States of America
State/province [1] 22466 0

Funding & Sponsors
Funding source category [1] 305384 0
University
Name [1] 305384 0
University of Adelaide
Country [1] 305384 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace
Adelaide, South Australia
5005
Country
Australia
Secondary sponsor category [1] 305763 0
None
Name [1] 305763 0
Address [1] 305763 0
Country [1] 305763 0
Other collaborator category [1] 281287 0
Commercial sector/Industry
Name [1] 281287 0
PaceMate
Address [1] 281287 0
518 13th St W
Bradenton, Florida
34205
Country [1] 281287 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305715 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 305715 0
Ethics committee country [1] 305715 0
Australia
Date submitted for ethics approval [1] 305715 0
03/04/2020
Approval date [1] 305715 0
14/04/2020
Ethics approval number [1] 305715 0
13019

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

Contacts
Principal investigator
Name 101326 0
Dr Catherine O'Shea
Address 101326 0
Royal Adelaide Hospital
Port Road, Adelaide
South Australia 5000
Country 101326 0
Australia
Phone 101326 0
+61 883139000
Fax 101326 0
Email 101326 0
[email protected]
Contact person for public queries
Name 101327 0
Catherine O'Shea
Address 101327 0
Royal Adelaide Hospital
Port Road, Adelaide
South Australia 5000
Country 101327 0
Australia
Phone 101327 0
+61 883139000
Fax 101327 0
Email 101327 0
[email protected]
Contact person for scientific queries
Name 101328 0
Catherine O'Shea
Address 101328 0
Royal Adelaide Hospital
Port Road, Adelaide
South Australia 5000
Country 101328 0
Australia
Phone 101328 0
+61 883139000
Fax 101328 0
Email 101328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data belongs to PaceMate, a private remote monitoring company.


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.