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NCT05016791: AFFU-AW
Apple Watch-led Surveillance of AF Recurrence After Catheter Ablation
NA trial testing Apple Watch-based heart rhythm monitoring in Atrial Fibrillation in 172 participants. Completed in 30 August 2024.
30 August 2024
Quick facts
| Lead sponsor | Barts & The London NHS Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 172 |
| Start date | 26 January 2022 |
| Primary completion | 30 August 2024 |
| Estimated completion | 30 August 2024 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Apple Watch-based heart rhythm monitoring
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
Barts & The London NHS Trust — full company profile →
Who can join
21 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Patient-Led Smartwatch ECG Follow-Up Strategy After AF Ablation : Clinical Trial Design and Implementation
Ahluwalia N, Abbass H, Hussain A, Saengkrajang G, et al · · 2026
Verify or expand the search:
- PubMed search for NCT05016791
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Apple Watch-based heart rhythm monitoring
Trials testing the same drug.
- NCT05007847 — Improving AF Detection in Cryptogenic Stroke · NA · completed
Other recruiting trials for Atrial Fibrillation
Currently open trials in the same condition.
- NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF · NA · recruiting
- NCT07271238 — Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures · NA · recruiting
- NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. · recruiting
- NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
- NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure · NA · recruiting
Other Barts & The London NHS Trust trials
Trials by the same sponsor.
- NCT05753085 — Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment · NA · withdrawn
- NCT07047235 — Substrate Remodelling and Targeted Ablation in AF · NA · recruiting
- NCT06871215 — Inflammation and Infective Endocarditis · withdrawn
- NCT07076524 — MuScle WastIng and DysphaGia iN CriticAlly IlL Patients (SIGNAL) · recruiting
- NCT06596486 — A Comparison of CoolStick With Ethyl Chloride for the Assessment of Light Touch · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05016791 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Barts & The London NHS Trust
- Last refreshed: 4 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05016791.
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