Atrial FibrillationAFFU-AWNCT05016791

Apple Watch-led Surveillance of AF Recurrence After Catheter Ablation

A study testing Apple Watch-based heart rhythm monitoring in people with Atrial Fibrillation, run by Barts & The London NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Apple Watch-based heart rhythm monitoring
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 172 participants
Where: 1 siteUnited Kingdom
Study dates: 26 Jan 2022to 30 Aug 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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Referred for first AFCA procedure by a Consultant electrophysiologist.
Paroxysmal or persistent AF captured on ECG but not in continuous AF for more than 3 years. (Paroxysmal AF is defined as an episode of AF that terminates spontaneously or with intervention within 7 days of onset. Persistent AF will be defined as any continuous episode lasting longer than 7 days or requiring intervention to restore sinus rhythm after this time.)
At least one episode of AF must have been documented by ECG or Holter within 12 months of inclusion in the study.
Continuous anticoagulation with warfarin (INR 2-3), low molecular weight heparin, or a novel oral anticoagulant (dabigatran, apixaban, rivaroxaban, edoxaban) for ≥4 weeks prior to the ablation; or a TEE that excludes LA thrombus ≤48 hours before ablation.
Access to a smartphone with Apple-operating system (OS) within their household for syncing with their watch.
Participants must be able and willing to provide written informed consent

Who cannot join

Patients with permanent AF. Permanent AF is defined as chronic, persisting AF (typically more than 1 year) for which cardioversion (pharmacologic or electrical) has failed or will never be attempted.
Patients with AF felt to be secondary to an obvious reversible cause.
Patients who are, or may potentially be pregnant.
Any cardiac implantable electronic device in situ or expected to undergo implantation in the next 12 months.
Previous left atrial (LA) ablation or LA surgery
Pre-existing pulmonary vein stenosis or PV stent

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Pre-existing hemi-diaphragmatic paralysis
Contraindication to anticoagulation or radiocontrast materials
Acute coronary syndrome within 4 weeks as defined by ECG ST segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g. troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent).
Cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrolment.
Life expectancy less than 1 year

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

St Bartholomew's Hospital
City of London, London, EC1A 7BE

Other trials in United Kingdom

About this study

Official title: Evaluating the Impact of Prolonged, Patient-led Heart Rhythm Surveillance With the Apple Watch on Detecting Arrhythmia Recurrence and Decision-making After Catheter Ablation of Atrial Fibrillation

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.

Conditions: Atrial Fibrillation
Being tested: Apple Watch-based heart rhythm monitoring
Keywords: atrial fibrillation, wearable
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Apple Watch-based heart rhythm monitoringDevice
For the duration of the study, participants in the active arm will be asked to make ECG recordings in three circumstances:
1. Routinely once per day from the day of randomisation till the 12-month visit after AF CA (they will be encouraged to do so at the same time each day with the option to set a reminder on the watch).
2. If the AW requests them to do so (the automatic AF-notification algorithm will be active throughout the study period and if AF is suspected based on the tachogram, it will trigger notification for the participant to make an ECG recording). This will be till the 12-month time point.
3. If the patient has symptoms of palpitations, pre-syncope or syncope. This will be till the 12-month time point. Monitoring should continue even if AF has been diagnosed to characterise arrhythmia burden and profile. Participants will be given the contact details of a dedicated email inbox to which to send ECGs recorded through the AW.

Study groups in NCT05016791
Study group	Role	What they receive
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. Receives: Device: Apple Watch-based heart rhythm monitoring
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to first documented recurrence of AF/AFl/AT
Measured: between days 91 to 365 after ablation

Secondary outcomes (4)

Time to first documented recurrence of symptomatic AF/AFl/AT
Measured: between days 91 and 365 after ablation
Freedom from AF and re-do AF CA procedures per patient at the 12 month timepoint.
Measured: 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 Atrial Fibrillation Quality of Life (AFeQT) survey. Min=20, Max=140. Higher score= worse outcome
Measured: 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
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jan 202230 Aug 2024

First posted23 Aug 2021
Study start26 Jan 2022
Primary completion30 Aug 2024
Study completion30 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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
Model description: 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.
Masking: None (open label)
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05016791
Sponsor's protocol ID: 292605
Acronym: AFFU-AW
Status last verified: Mar 2025
First submitted: 16 Jul 2021
Last updated: 4 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Impact of Prolonged, Patient-led Heart Rhythm Surveillance With the Apple Watch on Detecting Arrhythmia Recurrence and Decision-making After Catheter Ablation of Atrial Fibrillation
ClinicalTrials.gov ID: NCT05016791
Acronym / sponsor ID: AFFU-AW / 292605
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation, wearable
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: Barts & The London NHS TrustUniversity, hospital or other
Study start: 26 Jan 2022 (actual)
Primary completion: 30 Aug 2024 (actual)
Study completion: 30 Aug 2024 (actual)
First posted: 23 Aug 2021 (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.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Active	Active comparator	Device: Apple Watch-based heart rhythm monitoringParticipants 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Referred for first AFCA procedure by a Consultant electrophysiologist.
Paroxysmal or persistent AF captured on ECG but not in continuous AF for more than 3 years. (Paroxysmal AF is defined as an episode of AF that terminates spontaneously or with intervention within 7 days of onset. Persistent AF will be defined as any continuous episode lasting longer than 7 days or requiring intervention to restore sinus rhythm after this time.)
At least one episode of AF must have been documented by ECG or Holter within 12 months of inclusion in the study.
Continuous anticoagulation with warfarin (INR 2-3), low molecular weight heparin, or a novel oral anticoagulant (dabigatran, apixaban, rivaroxaban, edoxaban) for ≥4 weeks prior to the ablation; or a TEE that excludes LA thrombus ≤48 hours before ablation.
Access to a smartphone with Apple-operating system (OS) within their household for syncing with their watch.

Key exclusion criteria (11 listed)

Patients with permanent AF. Permanent AF is defined as chronic, persisting AF (typically more than 1 year) for which cardioversion (pharmacologic or electrical) has failed or will never be attempted.
Patients with AF felt to be secondary to an obvious reversible cause.
Patients who are, or may potentially be pregnant.
Any cardiac implantable electronic device in situ or expected to undergo implantation in the next 12 months.
Previous left atrial (LA) ablation or LA surgery

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
Apple Watch-based heart rhythm monitoringFor the duration of the study, participants in the active arm will be asked to make ECG recordings in three circumstances: 1. Routinely once per day from the day of randomisation till the 12-month visit after AF CA (they will be encouraged to do so at the same time each day with the option to set a reminder on the watch). 2. If the AW requests them to do so (the automatic AF-notification algorithm will be active throughout the study period and if AF is suspected based on the tachogram, it will trigger notification for the participant to make an ECG recording). This will be till the 12-month time point. 3. If the patient has symptoms of palpitations, pre-syncope or syncope. This will be till the 12-month time point. Monitoring should continue even if AF has been diagnosed to characterise arrhythmia burden and profile. Participants will be given the contact details of a dedicated email inbox to which to send ECGs recorded through the AW.	Device	Active

Primary outcome

Time to first documented recurrence of AF/AFl/AT
Time frame: between days 91 to 365 after ablation

4 secondary outcomes

Time to first documented recurrence of symptomatic AF/AFl/AT
Time frame: between days 91 and 365 after ablation
Freedom from AF and re-do AF CA procedures per patient at the 12 month timepoint.
Time frame: 1 year
The relative patient-reported satisfaction score in the active arm of the study compared to the control arm at 12 months.
Time frame: 1 year
The relative patient-reported satisfaction score in the active arm of the study compared to the control arm at 12 months.
Time frame: 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.

Richard Schilling principal investigator

Barts & The London NHS Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Apple Watch-based heart rhythm monitoring in people with Atrial Fibrillation, run by Barts & The London NHS Trust at 1 site in United Kingdom.

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 6 inclusion and 11 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: finished, as of the sponsor's last update on 4 Mar 2025. 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 United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 first documented recurrence of AF/AFl/AT (time frame: between days 91 to 365 after ablation). 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 NCT05016791.

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 4 Mar 2025.