Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000089831
Ethics application status
Approved
Date submitted
19/10/2020
Date registered
1/02/2021
Date last updated
1/03/2023
Date data sharing statement initially provided
1/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and Cost Effectiveness of Remote Monitoring in Patients with Implantable Loop Recorders
Scientific title
Efficacy and Cost Effectiveness of Remote Monitoring in Patients with Implantable Loop Recorders
Secondary ID [1] 301857 0
Nil known
Universal Trial Number (UTN)
U1111-1255-9240
Trial acronym
ECO-LOOP study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arrhythmia 318352 0
Condition category
Condition code
Cardiovascular 316359 316359 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study evaluates the role of remote monitoring for implantable loop recorders. It is an observational study and compares outcomes of patients monitored through remote monitoring versus conventional in-office follow up without remote monitoring. All participants will be monitored (through loop recorder) for at least a period of 18 months for cardiac arrhythmia's that lead to changes in the management of the condition such as implant of a pacemaker/ defibrillator or change in treatment such as oral anticoagulation or rate/ rhythm control medications. Interviews may take place every 6 months for at least 18 months and will be face to face or via telephone with a cardiologist. Interviews are expected to take 15 minutes.
Cost-effectiveness of remote monitoring for implantable loop recorders will also be assessed as remote monitoring may reduce the frequency of in-office visits.
Intervention code [1] 318148 0
Diagnosis / Prognosis
Comparator / control treatment
Conventional in-office follow up every 6-12 months as per treating cardiologist standard practice and appointments prompted by events such as syncope. This group will not be remotely monitored.
Control group
Active

Outcomes
Primary outcome [1] 324635 0
Composite Outcome of time between detection of significant bradycardia or tachycardia and decision to change in treatment or insertion of a Cardiac Implantable Electronic Device.
The presence of significant bradycardia or tachycardia will be assessed by device analytics, The change in treatment is determined by review of patient medical records and/or patient interview
Timepoint [1] 324635 0
Whenever an event occurs- as detected by remote monitoring alert or in-office checks.
A single patient may have more than one events during follow-up.

This will be assessed during follow up of at least 18 months (post-implant) or explant of the loop recorder, if the device is explanted within 18 months of the implant.
Primary outcome [2] 324636 0
The primary outcome is the time between new diagnosis of Atrial Fibrillation and commencement of oral anticoagulation based on CHADSVASc score of participants.
Detection of Atrial Fibrillation will be made from device interrogation reports.
The information on the commencement of oral anticoagulation will be obtained following the review of medical records and/or patient interview
Timepoint [2] 324636 0
Whenever a new diagnosis of AF is made - prompted by remote monitoring alerts or in-office check.

This will be assessed during follow up of at least 18 months (post-implant) or explant of the loop recorder, if the device is explanted within 18 months of the implant.
Primary outcome [3] 324638 0
Total scheduled and unscheduled clinic and hospital visits that are related to cardiac arrhythmia as determined from patient medical records and/or patient interview.
Timepoint [3] 324638 0
A minimum of 18 months (post-implant) or explant of the loop recorder, if the device is explanted within 18 months of the implant.

The analysis will be performed for (1) total number and (2) the number of visit per 12 months.
Secondary outcome [1] 385299 0
Composite secondary outcome for patients with syncope or cryptogenic stroke and the diagnostic yield (for each indication) of loop recorder as documented by device interrogation.
Timepoint [1] 385299 0
as prompted by remote monitoring alerts or in-office checks.

A minimum of 18 months (post-implant) or explant of the loop recorder, if the device is explanted within 18 months of the implant.
Secondary outcome [2] 385300 0
Participant adherence to scheduled follow-up visits, either remotely or in-office following review of patient medical records and/or patient interview.
Timepoint [2] 385300 0
A minimum of 18 months follow-up (post-implant) or explant of the loop recorder, if the device is explanted within 18 months of the implant.
Secondary outcome [3] 385301 0
Cost-effectiveness of remote monitoring based on Medicare costs in Australia
Timepoint [3] 385301 0
A minimum of 18 months follow-up or explant of the loop recorder, if the device is explanted within 18 months of the implant.

Eligibility
Key inclusion criteria
Patients with existing Implantable Loop Recorder for Syncope/Presyncope or Cryptogenic Stroke or due to having Implantable Loop Recorder inserted for these conditions
Can read and understand English
Data and follow up information available for at least 12 months after enrollment unless the patient had Loop Recorder explanted earlier than 12 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Follow up information unavailable
Non English Speaking
An inability to give Informed Consent

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
(1) Mean number of in-clinic and hospital visits
Using data from the TRUST trial (Varma N, Epstein AE, Irimpen A, Schweikert R, Love C. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation 2010;122:325–332) the mean number of visits (in-clinic + hospital) was 2.1 in the home monitoring group with a standard deviation (SD) of approximately 2.5, and 3.8 in the conventional group with a SD of approximately 1.7.
Using a conservative standard deviation of 2.5 for both groups, the sample size calculation resulted in a minimum total sample size of 94 (47 per group, power of 90% and alpha of 5%, 2-tailed).
(2) Time to clinical action after arrhythmic event
Using data from the TRUST Trial (Varma N, Epstein AE, Irimpen A, Schweikert R, Love C. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation 2010;122:325–332) for patients with AF, median time to clinical action after event was 5.5 days (IQR 1-51.25 days) in the remote monitoring group and 40 days (IQR 15.5-59 days) in the conventional group. So, as a rough estimate, using the median as mean and IQR/1.35 as the SD, we have a mean of 5.5 (SD =37.2) in the remote monitoring group vs 40 (32.2) in the conventional group. Using a power of this resulted in a required total sample size of 52 (26 per group, power of 90% and alpha of 5%, 2-tailed).
Thus, based on mean visits, we will aim for a minimal sample size of 94, with at least 47 in each group. Considering 10% drop out, a total of 104 participants with 52 in each group will be recruited.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/09/2020
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
104
Accrual to date
93
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 17194 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 30900 0
5035 - Ashford
Recruitment postcode(s) [2] 30899 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 306280 0
University
Name [1] 306280 0
University of Adelaide
Country [1] 306280 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Faculty of Health and Medical Sciences
University of Adelaide
North Terrace
Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 306869 0
None
Name [1] 306869 0
Address [1] 306869 0
Country [1] 306869 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306496 0
Central Adelaide Local Health Network
Ethics committee address [1] 306496 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [1] 306496 0
Australia
Date submitted for ethics approval [1] 306496 0
02/07/2020
Approval date [1] 306496 0
07/07/2020
Ethics approval number [1] 306496 0
13439

Summary
Brief summary
The study investigates the efficacy and cost-effectiveness of remote monitoring in patients with Implantable Loop Recorders, It is an observational study that collects data on time to detection of abnormal heart rhythms and clinical decision making in patients with and without remote monitoring attached to their devices. The utilization of health care resources (in-office visits) and cost-effectiveness of remote monitoring will be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104066 0
Dr Rajiv Mahajan
Address 104066 0
University of Adelaide Precinct
Level 2
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale 5112
SA
Country 104066 0
Australia
Phone 104066 0
+61 8 8182 9439
Fax 104066 0
Email 104066 0
rajiv.mahajan@adelaide.edu.au
Contact person for public queries
Name 104067 0
Dr Rajiv Mahajan
Address 104067 0
University of Adelaide Precinct
Level 2
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale 5112
SA
Country 104067 0
Australia
Phone 104067 0
+61 8 8182 9439
Fax 104067 0
Email 104067 0
rajiv.mahajan@adelaide.edu.au
Contact person for scientific queries
Name 104068 0
Dr Rajiv Mahajan
Address 104068 0
University of Adelaide Precinct
Level 2
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale 5112
SA
Country 104068 0
Australia
Phone 104068 0
+61 8 8182 9439
Fax 104068 0
Email 104068 0
rajiv.mahajan@adelaide.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
Not planned at this timepoint


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.