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Trial registered on ANZCTR


Registration number
ACTRN12620000641998
Ethics application status
Approved
Date submitted
22/05/2020
Date registered
1/06/2020
Date last updated
27/01/2021
Date data sharing statement initially provided
1/06/2020
Date results information initially provided
27/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Ventricular Arrhythmias in Implantable Cardioverter Defibrillator Patients During the COVID-19 Pandemic
Scientific title
Ventricular Arrhythmias in Implantable Cardioverter Defibrillator Patients During the COVID-19 Pandemic
Secondary ID [1] 301355 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 317578 0
Ventricular arrhythmias 317579 0
Implantable Cardioverter Defibrillators 317580 0
Condition category
Condition code
Cardiovascular 315664 315664 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
Our primary outcome is the impact of the COVID-19 pandemic on ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD) in situ.

Patients who are connected to the the PaceMate remote monitoring service during the COVID pandemic will be included. Data from these patients is automatically collected routinely as part of the PaceMate remote monitoring database. All ventricular arrhythmias occurring in ICD patients during the first 100 days of the COVID-19 pandemic in the USA will be included in the analysis (21st January until 29th April 2020).

For comparison, two further 100-day periods in 2019 will be included.
The first control period (CONTROL period) is to determine the impact of the COVID-19 period on ventricular arrhythmias. This will be a 100-day period prior to the COVID-19 pandemic (after excluding the Christmas period, 12th September to 21st December 2019).
The second control period (SEASONAL CONTROL period) is to control for potential seasonal variations. This will be the identical 100-day period, but one year prior. (21st January to 30th April 2019).
To allow direct comparison, only patients who are represented in both the COVID period and the respective control periods (CONTROL & SEASONAL CONTROL) will be included in the comparison analysis.

The study will require no participant involvement. Patients will have their ventricular arrhythmias recorded, as per usual, on the PaceMate database.
Intervention code [1] 317654 0
Not applicable
Comparator / control treatment
The control in this observational study are two time periods prior to COVID-19.
Data will be collected from each of the two control periods (CONTROL and SEASONAL CONTROL). All ventricular arrhythmias occurring during the two distinct control timeframes (Sept 12th-Dec 20th 2019, & January 21st until April 30th 2019) will be included in the analysis. These data will be derived from the PaceMate remote monitoring database.
Control group
Historical

Outcomes
Primary outcome [1] 323900 0
Primary Outcome- the impact of the COVID-19 pandemic on the occurrence of ventricular arrhythmias
This outcome will be measured by comparison of the number of ventricular arrhythmia episodes, and patients affected by ventricular arrhythmia episodes, between the COVID period, and the two control periods.
The number of ventricular arrhythmias, and the number of patients who experience a ventricular arrhythmia will be derived from the PaceMate remote monitoring database.
Timepoint [1] 323900 0
The primary outcome measure will be assessed daily during in each participant, during the 100-day COVID period, and daily during the two distinct 100-day control periods.
Secondary outcome [1] 383250 0
The impact of COVID-19 prevalence per US state, on the occurrence of ventricular arrhythmias in the patients receiving remote monitoring via PaceMate, in that state.

All US states in which PaceMate provides a remote monitoring service will be included in the analysis. COVID-19 prevalence rates per state, as of April 29th 2020 (end of 100-day COVID period) will be obtained from the US Centers for DIsease Control and Prevention (publically available information).
Per state COVID-19 prevalence will be correlated with per state ventricular arrhythmia rates during the COVID period.
Per state ventricular arrhythmia rates will be obtained via the PaceMate remote monitoring database.
Timepoint [1] 383250 0
The secondary outcome measure will be assessed by correlating per state ventricular arrhythmias (assessed daily during the 100-day COVID period) with per state COVID-19 prevalence (measured at a single timepoint- on the last day of the 100-day COVID period (29th April).

Eligibility
Key inclusion criteria
All patients with an implantable cardioverter defibrillator (ICD) in situ (inclusive of a standard ICD, a cardiac resynchronisation therapy defibrillator, or a subcutaneous ICD), who received remote monitoring of their ICD via the PaceMate remote monitoring service, during the first 100 days post the index confirmed COVID-19 case in USA.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Descriptive statistical analysis will beundertaken via Stata 16 (StataCorp LLC, TX, USA). Categorical variables will be expressed as a percentage. Continuous variables will be expressed as mean ± standard deviation. The primary endpoint of the study is the occurrence of ventricular arrhythmias (VT or VF events) in ICD patients receiving remote monitoring in the USA, via PaceMate, during the COVID-19 pandemic. The 100-day period following the confirmation of the first COVID-19 case within the USA (Early 2020) will be compared with the two 100-day control periods (Late 2019 and Early 2019). The number of patients who experienced a primary event during the Early 2020 period and the two control periods will be compared using McNemar’s test. The number of primary events occurring during Early 2020 and the two control periods will be compared via a Poisson regression analysis, with adjustment for age and COVID-19 cases in the relevant state. A two-sided p value of less than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2020
Actual
3/06/2020
Date of last participant enrolment
Anticipated
4/06/2020
Actual
4/06/2020
Date of last data collection
Anticipated
5/06/2020
Actual
5/06/2020
Sample size
Target
6000
Accrual to date
Final
5963
Recruitment in Australia
Recruitment state(s)
SA
Recruitment outside Australia
Country [1] 22568 0
United States of America
State/province [1] 22568 0
Alabama Colorado Illinois Kansas Kentucky Louisiana Maine New Jersey Ohio Oklahoma South Carolina Texas Virginia

Funding & Sponsors
Funding source category [1] 305795 0
University
Name [1] 305795 0
The University of Adelaide
Country [1] 305795 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace
Adelaide SA 5000
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 306233 0
None
Name [1] 306233 0
Address [1] 306233 0
Country [1] 306233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306066 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 306066 0
Royal Adelaide Hospital
Port Rd
Adelaide SA 5000
Ethics committee country [1] 306066 0
Australia
Date submitted for ethics approval [1] 306066 0
22/05/2020
Approval date [1] 306066 0
02/06/2020
Ethics approval number [1] 306066 0
13290

Summary
Brief summary
PRIMARY PURPOSE OF STUDY & STUDY HYPOTHESIS:
The primary purpose of this study is to assess the incidence of life-threatening heart rhythms in patients with an implantable defibrillator during the early coronavirus pandemic, compared with the months prior.
Physical activity and illness, emotional distress and significant world events (including earthquakes, major sporting matches, and the 9/11 World Trade Center attack) have all been shown to correlate with a increase in life-threatening heart rhythms.
We hypothesise that the COVID-19 pandemic will similarly be associated with a rise in life-threatening heart rhythms in defibrillator patients, who have a predisposition to such heart rhythms.
To establish this, we plan to to assess all life-threatening heart rhythms in defibrillator patients during the first 100 days of the COVID-19 pandemic in the United States of America, compared with a 100-day period at the end of 2019, prior to the pandemic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102578 0
Dr Catherine O'Shea
Address 102578 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 102578 0
Australia
Phone 102578 0
+61870740000
Fax 102578 0
Email 102578 0
[email protected]
Contact person for public queries
Name 102579 0
Catherine O'Shea
Address 102579 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 102579 0
Australia
Phone 102579 0
+61870740000
Fax 102579 0
Email 102579 0
[email protected]
Contact person for scientific queries
Name 102580 0
Catherine O'Shea
Address 102580 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 102580 0
Australia
Phone 102580 0
+61870740000
Fax 102580 0
Email 102580 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 remote monitoring company


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Published in European Heart Journal- 16th December... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseVentricular arrhythmia burden during the coronavirus disease 2019 (COVID-19) pandemic.2021https://dx.doi.org/10.1093/eurheartj/ehaa893
N.B. These documents automatically identified may not have been verified by the study sponsor.