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

Not Applicable

Completed

• Conditions: Ventricular arrhythmias; Cardiovascular - Other cardiovascular diseases; COVID-19; Implantable Cardioverter Defibrillators

• Registration Number: ACTRN12620000641998
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-01
• Study Completion: 2020-06-05
• Last Update Posted: 1 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5963

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

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome- the impact of the COVID-19 pandemic on the occurrence of ventricular arrhythmias<br>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.<br>The number of ventricular arrhythmias, and the number of patients who experience a ventricular arrhythmia will be derived from the PaceMate remote monitoring database.[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 Measures

Name	Time	Method
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.<br><br>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).<br>Per state COVID-19 prevalence will be correlated with per state ventricular arrhythmia rates during the COVID period.<br>Per state ventricular arrhythmia rates will be obtained via the PaceMate remote monitoring database.[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).]