Standard of Care for Atrial Fibrillation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atrial Fibrillation+3 More
Holter monitoring - DiagnosticTest
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is investigating whether the Kardia Mobile monitoring device is a superior strategy for diagnosing Atrial Fibrillation (AF) in comparison to normal ambulatory monitoring with a 24-hour Holter monitor.

Eligible Conditions
  • Atrial Fibrillation
  • Paroxysmal atrial fibrillation
  • Cardiovascular Diseases
  • Arrhythmias, Cardiac

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 6 months

6 months
Time to atrial fibrillation diagnosis compared between arms as analysed by Kaplan-Meier survival curves

Trial Safety

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Enhanced Monitoring
1 of 2

Active Control

220 Total Participants · 2 Treatment Groups

Primary Treatment: Standard of Care · No Placebo Group · N/A

Standard of Care
DiagnosticTest
ActiveComparator Group · 1 Intervention: Holter monitoring · Intervention Types: DiagnosticTest
Enhanced MonitoringActiveComparator Group · 2 Interventions: Holter monitoring, Kardia/AliveCor monitoring · Intervention Types: DiagnosticTest, DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Victoria Cardiac Arrhythmia TrialsLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Markus Sikkel, MDPrincipal InvestigatorVictoria Cardiac Arrhythmia Trials Inc.

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have symptoms that may be due to arrhythmia.
You have at least one risk factor from CHADS-65 CCS Algorithm.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: November 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.