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Atrial Fibrillation in Patients with an Implantable Cardiac Device during the COVID-19 Pandemic

Atrial Fibrillation in patients with a permanent pacemaker or implantable cardioverter defibrillator during the COVID-19 Pandemic

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000692932
Enrollment
10346
Registered
2020-06-22
Start date
2020-06-27
Completion date
2020-06-28
Last updated
2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

The University of Adelaide
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
5 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Patients without active use of an atrial lead in their PPM/ICD, as determined by device programming parameters.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 15, 2026