Early Diagnosis of Atrial Fibrillation in the Wait-Time Prior to Seeing a Cardiologist

NCT04302311 | Active Not Recruiting

• 1 other identifier: 101792
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized patient-oriented trial to investigate whether continual symptomatic use of 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. Patients with referrals to an Electrophysiologist, symptoms of AF but no documentation of AF, and with at least one stroke risk factor based on the CHADS2 scoring system are randomized 1:1 to Kardia Mobile monitoring versus Holter monitoring alone.

Conditions

Atrial Fibrillation; Atrial Fibrillation Paroxysmal; Arrhythmias, Cardiac; Cardiovascular Diseases

Keywords

Electrophysiology; Holter monitoring; Kardia/AliveCor; Stroke risk factors; Diagnosis of arrhythmias; Smart device technology

Outcome Measures

Primary Outcomes (1)

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

  using the Log-rank test.

  6 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Holter monitoring

Diagnostic Test: Holter monitoring

Enhanced Monitoring

ACTIVE COMPARATOR

Kardia/AliveCor monitoring with additional Holter monitoring as needed

Diagnostic Test: Holter monitoring; Diagnostic Test: Kardia/AliveCor monitoring

Interventions

Holter monitoring DIAGNOSTIC_TEST

Use of smart device application and technologies to assess for arrhythmias

Also known as: Atrial Fibrillation Diagnostic Testing

Enhanced Monitoring; Standard of Care

Kardia/AliveCor monitoring DIAGNOSTIC_TEST

Kardia/AliveCor monitoring

Also known as: Atrial Fibrillation Diagnostic Testing

Enhanced Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Referral for episodic symptoms that may be due to arrhythmia (e.g. palpitations, dyspnea, or pre-syncope)
• At least one risk factor from CHADS-65 CCS Algorithm

You may not qualify if:

• Previous diagnosis of atrial fibrillation
• Already anticoagulated for another diagnosis (e.g. metallic heart valve or pulmonary embolism)
• Symptoms typical of non-arrhythmic cause (e.g. exertional chest pain)

Sponsors & Collaborators

• Victoria Cardiac Arrhythmia Trials: lead

Study Sites (1)

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, V8Z 0B9, Canada

Location

Related Publications (1)

• Coxon MW, Hoskin K, van Zyl M, Thibert M, Sikkel M. Catch-AF-Early Diagnosis of Symptomatic Arrythmias in the Waiting Period Prior to Seeing a Cardiologist in Victoria, British Columbia. CJC Open. 2024 Sep 25;6(12):1476-1483. doi: 10.1016/j.cjco.2024.09.007. eCollection 2024 Dec.

  PMID: 39735942 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Cardiovascular Diseases

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Markus Sikkel, MD

  Victoria Cardiac Arrhythmia Trials Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: December 18, 2018
• Primary Completion: October 21, 2022
• Study Completion: March 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)