Atrial FibrillationCATCH-AFNCT04302311
Early Diagnosis of Atrial Fibrillation in the Wait-Time Prior to Seeing a Cardiologist
A study testing Holter monitoring and Kardia/AliveCor monitoring in people with Atrial Fibrillation and Atrial Fibrillation Paroxysmal, run by Victoria Cardiac Arrhythmia Trials at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Fibrillation Paroxysmal, Arrhythmias, Cardiac
- What is being tested?
- Holter monitoring and Kardia/AliveCor monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteCanada
- Study dates
- 18 Dec 2018to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, V8Z 0B9
About this study
Official title: Early Diagnosis of Atrial Fibrillation in the Wait-Time Prior to Seeing a Cardiologist (CATCH-AF)
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.
Read the detailed description
Wait-times from referral by a family practitioner to seeing a specialist have increased greatly over the past 10 years in Canada. The Fraser institute reports an 11 week wait-time in BC in 20161. Our experience is that this is representative of the wait-time to see a cardiologist at our institute.
Family doctors can diagnose some cases of atrial fibrillation (AF) with a pulse check and 12-lead electrocardiogram (ECG). However this is the minority of patients and most diagnoses are made on the basis of more prolonged ambulatory ECG recordings as part of the investigation of paroxysmal symptoms by a specialist2.
There is an increasing prevalence of AF3 and the consequences of late diagnosis can be dire. For example a 76 year old lady with treated hypertension and yet to be diagnosed paroxysmal AF has a risk of 6.7% per year of suffering stroke, TIA or systemic thromboembolus4. During the ~11 week wait for an appointment plus a further ~8 week wait for thorough diagnostic testing and further follow up she therefore has a 2.5% risk of having an event. If this is multiplied across the thousands of patients waiting for appointments across Canada over the course of a year it is evident that numerous thromboembolic complications could be prevented through reduction of the time to diagnosis.
Furthermore the first-line investigation for diagnosis of paroxysmal arrhythmia is usually an ambulatory ECG monitor (Holter/Event monitor)5,6. However, patients frequently do not have symptoms during the period of monitoring and the diagnostic yield is between 15% and 39%7-10.
Implantable loop recorders (ILRs) can provide accurate and thorough ECG monitoring continuously for up to 3 years. However, they are used late in the diagnostic process and are too expensive for widespread use for AF screening and so can only have a limited impact on overall time to diagnosis.
We therefore have two main problems in early AF diagnosis with paroxysmal symptoms. First that patients are waiting a long time for diagnostic tests and second that the diagnostic tools usually used by clinicians are not particularly good at picking up AF. We believe both issues can be tackled through use of the Karda Mobile in the wait-time prior to an appointment with a specialist.
The Kardia Mobile (AliveCor, San Francisco) is a validated, CE marked, single channel ECG recorder that can be paired with a smartphone. It has a high sensitivity (98%) and specificity (97%) for AF diagnosis11. This device allows intermittent patient-driven monitoring based on symptoms. Since smartphones are now owned by 68% of Canadians, most patients can now access this tool12.
We hypothesize that the Kardia Mobile could be an excellent tool for the diagnosis of AF in the wait-time prior to seeing a cardiologist. We aim to expand the role of our AF clinic at the Royal Jubilee Hospital, Victoria, BC by introducing enhanced wait- time arrhythmia diagnostics using the Kardia in this pilot study.
We will enrol patients at high risk for thromboembolus (score≥1 as per CHADS-65 CCS algorithm13) who are awaiting an appointment with a cardiologist in our locality for investigation of paroxysmal symptoms that may be caused by arrhythmia. These patients will either have standard care with a 24h Holter monitor or enhanced monitoring using the Kardia Mobile in addition to standard Holter monitoring.
We aim to test whether using the Kardia Mobile during the wait-time can reduce the time to diagnosis of AF
- Conditions
- Atrial Fibrillation, Atrial Fibrillation Paroxysmal, Arrhythmias, Cardiac, Cardiovascular Diseases
- Being tested
- Holter monitoring, Kardia/AliveCor monitoring
- Keywords
- Electrophysiology, Holter monitoring, Kardia/AliveCor, Stroke risk factors, Diagnosis of arrhythmias, Smart device technology
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter monitoringDiagnostic test
Also called Atrial Fibrillation Diagnostic Testing
Use of smart device application and technologies to assess for arrhythmias
Kardia/AliveCor monitoringDiagnostic test
Also called Atrial Fibrillation Diagnostic Testing
Kardia/AliveCor monitoring
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Holter monitoring Receives: Diagnostic Test: Holter monitoring |
| Enhanced Monitoring | Active comparator | Kardia/AliveCor monitoring with additional Holter monitoring as needed Receives: Diagnostic Test: Holter monitoring; Diagnostic Test: Kardia/AliveCor monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to atrial fibrillation diagnosis compared between arms as analysed by Kaplan-Meier survival curves
using the Log-rank test.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start18 Dec 2018
- Primary completion21 Oct 2022
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victoria Cardiac Arrhythmia Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Sikkel, MD, Principal investigator, Victoria Cardiac Arrhythmia Trials Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302311
- Sponsor's protocol ID
- 101792
- Acronym
- CATCH-AF
- Status last verified
- Feb 2024
- First submitted
- 6 Mar 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39735942
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Atrial Fibrillation in the Wait-Time Prior to Seeing a Cardiologist (CATCH-AF)
- ClinicalTrials.gov ID
- NCT04302311
- Acronym / sponsor ID
- CATCH-AF / 101792
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Victoria Cardiac Arrhythmia TrialsUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- Mar 2024 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Wait-times from referral by a family practitioner to seeing a specialist have increased greatly over the past 10 years in Canada. The Fraser institute reports an 11 week wait-time in BC in 20161. Our experience is that this is representative of the wait-time to see a cardiologist at our institute.
Family doctors can diagnose some cases of atrial fibrillation (AF) with a pulse check and 12-lead electrocardiogram (ECG). However this is the minority of patients and most diagnoses are made on the basis of more prolonged ambulatory ECG recordings as part of the investigation of paroxysmal symptoms by a specialist2.
There is an increasing prevalence of AF3 and the consequences of late diagnosis can be dire. For example a 76 year old lady with treated hypertension and yet to be diagnosed paroxysmal AF has a risk of 6.7% per year of suffering stroke, TIA or systemic thromboembolus4. During the ~11 week wait for an appointment plus a further ~8 week wait for thorough diagnostic testing and further follow up she therefore has a 2.5% risk of having an event. If this is multiplied across the thousands of patients waiting for appointments across Canada over the course of a year it is evident that numerous thromboembolic complications could be prevented through reduction of the time to diagnosis.
Furthermore the first-line investigation for diagnosis of paroxysmal arrhythmia is usually an ambulatory ECG monitor (Holter/Event monitor)5,6. However, patients frequently do not have symptoms during the period of monitoring and the diagnostic yield is between 15% and 39%7-10.
Implantable loop recorders (ILRs) can provide accurate and thorough ECG monitoring continuously for up to 3 years. However, they are used late in the diagnostic process and are too expensive for widespread use for AF screening and so can only have a limited impact on overall time to diagnosis.
We therefore have two main problems in early AF diagnosis with paroxysmal symptoms. First that patients are waiting a long time for diagnostic tests and second that the diagnostic tools usually used by clinicians are not particularly good at picking up AF. We believe both issues can be tackled through use of the Karda Mobile in the wait-time prior to an appointment with a specialist.
The Kardia Mobile (AliveCor, San Francisco) is a validated, CE marked, single channel ECG recorder that can be paired with a smartphone. It has a high sensitivity (98%) and specificity (97%) for AF diagnosis11. This device allows intermittent patient-driven monitoring based on symptoms. Since smartphones are now owned by 68% of Canadians, most patients can now access this tool12.
We hypothesize that the Kardia Mobile could be an excellent tool for the diagnosis of AF in the wait-time prior to seeing a cardiologist. We aim to expand the role of our AF clinic at the Royal Jubilee Hospital, Victoria, BC by introducing enhanced wait- time arrhythmia diagnostics using the Kardia in this pilot study.
We will enrol patients at high risk for thromboembolus (score≥1 as per CHADS-65 CCS algorithm13) who are awaiting an appointment with a cardiologist in our locality for investigation of paroxysmal symptoms that may be caused by arrhythmia. These patients will either have standard care with a 24h Holter monitor or enhanced monitoring using the Kardia Mobile in addition to standard Holter monitoring.
We aim to test whether using the Kardia Mobile during the wait-time can reduce the time to diagnosis of AF
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Diagnostic Test: Holter monitoringHolter monitoring |
| Enhanced Monitoring | Active comparator | Diagnostic Test: Holter monitoring, Diagnostic Test: Kardia/AliveCor monitoringKardia/AliveCor monitoring with additional Holter monitoring as needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holter monitoringAlso: Atrial Fibrillation Diagnostic TestingUse of smart device application and technologies to assess for arrhythmias | Diagnostic test | Enhanced Monitoring, Standard of Care |
| Kardia/AliveCor monitoringAlso: Atrial Fibrillation Diagnostic TestingKardia/AliveCor monitoring | Diagnostic test | Enhanced Monitoring |
Primary outcome
Time to atrial fibrillation diagnosis compared between arms as analysed by Kaplan-Meier survival curves
Time frame: 6 months
using the Log-rank test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 39735942Coxon 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.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Sikkel, MD principal investigator
Victoria Cardiac Arrhythmia Trials Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holter monitoring and Kardia/AliveCor monitoring in people with Atrial Fibrillation and Atrial Fibrillation Paroxysmal, run by Victoria Cardiac Arrhythmia Trials at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to atrial fibrillation diagnosis compared between arms as analysed by Kaplan-Meier survival curves (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04302311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.