Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000692932
Ethics application status
Approved
Date submitted
12/06/2020
Date registered
22/06/2020
Date last updated
30/06/2021
Date data sharing statement initially provided
22/06/2020
Date results information initially provided
30/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Atrial Fibrillation in Patients with an Implantable Cardiac Device during the COVID-19 Pandemic
Scientific title
Atrial Fibrillation in patients with a permanent pacemaker or implantable cardioverter defibrillator during the COVID-19 Pandemic
Secondary ID [1] 301508 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 317845 0
Permanent pacemaker 317846 0
Implantable cardioverter defibrillator 317847 0
Condition category
Condition code
Cardiovascular 315898 315898 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
100
Target follow-up type
Days
Description of intervention(s) / exposure
Our primary outcome is the impact of the COVID-19 pandemic on atrial fibrillation (AF) in patients with a permanent pacemaker (PPM) or 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 AF episodes occurring in PPM and 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, a 100-day Control periods will be included.
The control period is to account 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 Control period will be included in the comparison analysis.

The study will require no participant involvement. Patients will have their AF episodes recorded, as per usual, on the PaceMate database.
Intervention code [1] 317815 0
Not applicable
Comparator / control treatment
The control in this observational study is a time period prior to COVID-19.
Data will be collected from the Control period. All AF episodes occurring during the Control period (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] 324108 0
Primary Outcome- the impact of the COVID-19 pandemic on the occurrence of AF.
This outcome will be measured by comparison of the number of AF episodes, and number of patients affected by AF episodes, between the COVID period, and Control periods.
The number of AF episodes, and the number of patients who experience an AF episode will be derived from the PaceMate remote monitoring database.
Timepoint [1] 324108 0
The primary outcome measure will be assessed daily during in each participant, during the 100-day COVID period, and daily during the 100-day Control period.
Secondary outcome [1] 383778 0
The impact of COVID-19 prevalence per US state, on the occurrence of AF 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 AF rates during the COVID period.
Per state AF rates will be obtained via the PaceMate remote monitoring database.
Timepoint [1] 383778 0
The secondary outcome measure will be assessed by correlating per state AF rates (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 2020).

Eligibility
Key inclusion criteria
All patients with a permanent pacemaker (PPM- inclusive of a standard PPM or cardiac resynchronisation therapy PPM) or an implantable cardioverter defibrillator (ICD- inclusive of a standard ICD, or a cardiac resynchronisation therapy ICD) in situ, who received remote monitoring of their PPM/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
Patients without active use of an atrial lead in their PPM/ICD, as determined by device programming parameters.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Descriptive statistical analysis will be undertaken 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 atrial fibrillation in PPM/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 Control period (Early 2019). The number of patients who experienced a primary event during the Early 2020 period and the Control period will be compared using McNemar’s test. The number of primary events occurring during Early 2020 and the Control period 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
24/06/2020
Actual
27/06/2020
Date of last participant enrolment
Anticipated
25/06/2020
Actual
28/06/2020
Date of last data collection
Anticipated
25/06/2020
Actual
28/06/2020
Sample size
Target
10000
Accrual to date
Final
10346
Recruitment outside Australia
Country [1] 22669 0
United States of America
State/province [1] 22669 0
Alabama, Colorado, Illinois, Kansas, Kentucky, Louisiana, Maine, New Jersey, Ohio, Oklahoma, South Carolina, Texas, Virginia

Funding & Sponsors
Funding source category [1] 305949 0
University
Name [1] 305949 0
The University of Adelaide
Country [1] 305949 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace
Adelaide SA 5000
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 306404 0
None
Name [1] 306404 0
Address [1] 306404 0
Country [1] 306404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306192 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 306192 0
Royal Adelaide Hospital
Port Rd
Adelaide SA 5000
Ethics committee country [1] 306192 0
Australia
Date submitted for ethics approval [1] 306192 0
12/06/2020
Approval date [1] 306192 0
26/06/2020
Ethics approval number [1] 306192 0

Summary
Brief summary
PRIMARY PURPOSE OF STUDY & STUDY HYPOTHESIS:
The primary purpose of this study is to assess the incidence of an abnormal heart rhythm, atrial fibrillation, in patients with a permanent pacemaker or implantable defibrillator during the early coronavirus pandemic, compared with the months prior.
A sedentary lifestyle, alcohol intake, and weight gain have all been shown to correlate with atrial fibrillation.
We hypothesise that the COVID-19 pandemic will be associated with a rise in atrial fibrillation in pacemaker and defibrillator patients, who have a predisposition to such heart rhythms.
To establish this, we plan to to assess all atrial fibrillation episodes in pacemaker and defibrillator patients during the first 100 days of the COVID-19 pandemic in the United States of America, compared the same 100-day period in Early 2019.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103034 0
Prof Prashanthan Sanders
Address 103034 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 103034 0
Australia
Phone 103034 0
+61 870740000
Fax 103034 0
Email 103034 0
[email protected]
Contact person for public queries
Name 103035 0
Prof Prashanthan Sanders
Address 103035 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 103035 0
Australia
Phone 103035 0
+61 870740000
Fax 103035 0
Email 103035 0
[email protected]
Contact person for scientific queries
Name 103036 0
Prof Prashanthan Sanders
Address 103036 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 103036 0
Australia
Phone 103036 0
+61 870740000
Fax 103036 0
Email 103036 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAtrial fibrillation burden during the coronavirus disease 2019 pandemic.2021https://dx.doi.org/10.1093/europace/euab099
N.B. These documents automatically identified may not have been verified by the study sponsor.