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Ventricular Arrhythmias in Implantable Cardioverter Defibrillator Patients During the COVID-19 Pandemic

Ventricular Arrhythmias in Implantable Cardioverter Defibrillator Patients During the COVID-19 Pandemic

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000641998
Enrollment
5963
Registered
2020-06-01
Start date
2020-06-03
Completion date
2020-06-04
Last updated
2021-02-01

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 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.

Interventions

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

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.

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 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.

Exclusion criteria

Nil

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026