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Atrial fibrillation (AF) is a heart rhythm disorder associated with debillitating symptoms, psychological distress and heart failure. It can also significantly increase an individuals stroke risk. Catheter ablation (CA) for AF is the most effective way to restore normal heart rhythm. However, AF can recur in up to 50% of patients after their first CA procedure and a second 'top-up' procedure may be needed to maximise effect. Early detection of recurrences can enable planning and treatment and repeat CA procedures.
Post-CA follow-up strategies rely on episodic rhythm monitoring (Holter monitor tests) that usually last between 1 and 7 days. However, AF recurrences can be intermittent and may not occur during these short monitoring episodes. A greater duration of monitoring has been shown to yield greater detection of AF recurrences.
Relying on symptoms alone to detect recurrence is also sub-optimal. AF recurrences can also be insidious. Similar symptoms may be reported from ectopy, atrial tachycardias or atrial flutter. These may require different management approaches, necessitating rhythm characterisation before considering a repeat CA.
The Apple Watch (AW) is a wristwatch that is able to monitor a wearer's heart rate and rhythm regularity as well as facilitating an immediate, real-time single-lead ECG recording. This non-invasive device that can be purchased over- the-counter has demonstrated feasibility in detecting AF and may offer a potential non-invasive, alternative long-term rhythm surveillance strategy to diagnose AF in these patients.
The investigators propose a single-centre, randomised controlled study to compare the standard follow-up strategy after index AF CA versus one supplemented with an AW-led prolonged monitoring strategy to determine if the latter will improve the expediency and rate of AF recurrence detection. Whether this will lead to improved downstream decision-making, reduction in symptomatic events and a lower prevalence of AF in the longer term will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Participants shall receive standard care and follow-up as provided by their clinical care provider. Heart rhythm monitoring tests shall be performed as per their clinical care provider. In addition, participants in this arm shall be loaned an Apple Watch device and undergo an education session to familiarise themselves with the study recording schedule and how to perform recordings. |
|
| Control | No Intervention | Participants shall receive standard care and follow-up as provided by their clinical care provider. Heart rhythm monitoring tests shall be performed as per their clinical care provider. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple Watch-based heart rhythm monitoring | Device | For the duration of the study, participants in the active arm will be asked to make ECG recordings in three circumstances:
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first documented recurrence of AF/AFl/AT | between days 91 to 365 after ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first documented recurrence of symptomatic AF/AFl/AT | between days 91 and 365 after ablation | |
| Freedom from AF and re-do AF CA procedures per patient at the 12 month timepoint. | 1 year | |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the atrial tachyarrhythmia burden during the blanking period (day 0 to day 90 post ablation) and documented recurrence of AF/AFl/AT after the blanking period ( day 91 to day 365 after ablation). | active arm of the study only | 1 year |
| Per-subject comparison of accelerometer-derived activity levels during sinus rhythm as compared to atrial arrhythmia in patients who have a paroxysmal atrial arrhythmia recurrence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Schilling | Barts & The London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Bartholomew's Hospital | City of London | London | EC1A 7BE | United Kingdom |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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A prospective, randomised controlled trial to compare the standard follow-up pathway after AF catheter ablation against the standard pathway augmented with Apple Watch-based rhythm monitoring. The endpoints will be the time to detection of AF recurrence and downstream sequelae such as the number of repeat ablation procedures, and longer-term freedom from AF.
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Participants will be randomised after enrollment to active or control arms of this study
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|
| The relative patient-reported satisfaction score in the active arm of the study compared to the control arm at 12 months. |
Using the Atrial Fibrillation Quality of Life (AFeQT) survey. Min=20, Max=140. Higher score= worse outcome |
| 1 year |
| The relative patient-reported satisfaction score in the active arm of the study compared to the control arm at 12 months. | Using the Barts Atrial Fibrillation Patient Reported Outcome Measure survey. Min=28, Max=140. Higher score= worse outcome | 1 year |
active arm of the study only |
| 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |