Remote Monitoring of AF Recurrence Using mHealth Technology

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is the most common arrhythmia worldwide. It carries a significant health burden, conferring on sufferers a reduction in quality of life, risk of significant morbidities such as stroke and heart failure, and significant mortality. At present, diagnosis of AF involves referral for conventional 12 lead electrocardiogram (ECG) recording, ambulatory ECG for fixed time period recording, or insertion of implantable loop recorders (ILR). These investigations are limited both by recording only at specific time points and failing to explore the interaction between heart rate and day-to-day physical activity. In recent years, the use of mobile health (mHealth) devices has emerged as a direct-to-consumer option for monitoring parameters such as heart rate and activity levels. From a clinical perspective they potentially offer a less invasive and cost-effective investigative approach, with remote monitoring solution to identify and possibly predict AF. In this study, the investigators propose to recruit participants who have undergone an ablative procedure as part of a randomised clinical trial (LoTO in CASA LSPAF: NCT04280042) and monitor for recurrence of AF using mHealth technology by correlating with ILR data.

Official Title
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Remote Monitoring of AF Recurrence Using mHealth Technology (REMOTE-AF)

Conditions
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Long Standing Persistent Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in LoTO in CASA LSPAF with implanted loop recorders (ILR) Exclusion Criteria: Participants in LoTO in CASA LSPAF who had their ILR explanted

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ablation<br>Participants recruited from the LoTO_CASA_AF trial (ClinicalTrials.gov Identifier: NCT04280042) who underwent either conventional catheter ablation or thoracoscopic surgical ablation to treat their long standing persistent AF with be asked to continue downloading data from their implanted loop recorder and monitor their heart rate and physical activity level (step count) using a wrist worn activity tracker. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore if mHealth obtained heart rate (PPG) data can be correlated to recurrence of AF/AT in patients who have undergone an ablative procedure. | Exploring a correlation between PPG data from a wrist worn device and atrial arrhythmias recorded by implantable loop recorder or other clinically indicated rhythm recording device. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Digital health, Artificial intelligence, Catheter ablation, Thoracoscopic surgical AF ablation