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Virtual Care System for Atrial Fibrillation

N/A
Waitlist Available
Led By Allan C Skanes, Md
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented symptomatic new-onset or pre-existing, non-valvular AF
Be older than 18 years old
Must not have
Planned percutaneous coronary intervention, coronary artery bypass graphing or heart valve surgery within the next year
Unable to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 12 months
Awards & highlights

Summary

This trial will use a chart review to study the characteristics of atrial fibrillation patients who go to the emergency room, and will also provide patients with an electronic health care system and a heart rhythm sensor.

Who is the study for?
This trial is for English-speaking adults with non-valvular atrial fibrillation who've been to the ER or hospitalized for it in the last 6 months. They must be able to consent and have a smart device with Bluetooth. It's not for those planning major heart surgery, likely to move, pregnant, incarcerated, or with a life expectancy under one year.
What is being tested?
The VIRTUES study tests an electronic health system paired with a Health Canada approved heart rhythm sensor for AF patients. The goal is to reduce ER visits by allowing patients to record symptoms and receive real-time advice from a heart rhythm team.
What are the potential side effects?
Since this trial involves using an electronic healthcare system and wearable sensor rather than medication, traditional side effects are not expected. However, there may be discomfort or skin irritation from wearing the sensor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a type of irregular heartbeat not caused by a heart valve issue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for heart surgery or a procedure to improve blood flow to the heart within the next year.
Select...
I am unable to understand and agree to the study's details on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients who present to the emergency department due to atrial fibrillation, after their index visit
Secondary study objectives
Frequency of stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death
Number of AF-related ER visit per patient, post index visit
Pre and post patient reported outcomes using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire and the EQ-5D-5L
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: VIRTUES ArmExperimental Treatment1 Intervention
Patients in the VIRTUES arm will be offered enrollment into the virtual atrial fibrillation care platform.

Find a Location

Who is running the clinical trial?

Cardiac Arrhythmia Network of CanadaOTHER
11 Previous Clinical Trials
7,369 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
2,649 Patients Enrolled for Atrial Fibrillation
Lawson Health Research InstituteLead Sponsor
672 Previous Clinical Trials
414,211 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
7,214 Patients Enrolled for Atrial Fibrillation
Allan C Skanes, MdPrincipal InvestigatorLawson Health Research Institute

Media Library

VIRTUES Clinical Trial Eligibility Overview. Trial Name: NCT04599114 — N/A
Atrial Fibrillation Research Study Groups: VIRTUES Arm
Atrial Fibrillation Clinical Trial 2023: VIRTUES Highlights & Side Effects. Trial Name: NCT04599114 — N/A
VIRTUES 2023 Treatment Timeline for Medical Study. Trial Name: NCT04599114 — N/A
~62 spots leftby Sep 2025
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