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NCT05007847: CSAF-AW
Improving AF Detection in Cryptogenic Stroke
NA trial testing Apple Watch-based heart rhythm monitoring in Cryptogenic Stroke in 27 participants. Completed in 28 February 2025.
28 February 2025
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 | 27 |
| Start date | 4 February 2022 |
| Primary completion | 28 February 2025 |
| Estimated completion | 28 February 2025 |
| Sites | 4 locations across United Kingdom |
Drugs / interventions tested
- Apple Watch-based heart rhythm monitoring
Conditions studied
- Cryptogenic Stroke — all drugs for Cryptogenic Stroke →
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
Barts & The London NHS Trust — full company profile →
Who can join
30 and older, any sex, with Cryptogenic Stroke or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
No cause for stroke is found in up to 30% of cases despite extensive investigations. These are called cryptogenic strokes (CS). 1 in 4 stroke survivors will suffer another in 5 years and this is a leading cause of fear and anxiety. A common reason for CS is an undetected heart rhythm disorder called atrial fibrillation (AF). AF occurs intermittently, so it may not be detected during the mandated 24-96 hours of rhythm monitoring that is performed as part of the standard post-stroke investigation strategy. A randomised controlled study in 2014 showed that whereas this standard monitoring strategy picks up AF in 2% of CS patients, longer-term, continuous monitoring for 12 months can pick up AF in 13% of patients. This suggests the standard strategy may miss AF in a proportion of CS patients and thus also the opportunity to mitigate against further strokes with anticoagulation therapy. Prolonged monitoring has traditionally required a minimally-invasive surgical procedure to implant a recording device under the skin at a specialist centre. A specifically trained team is also required to interpret the large number of recordings this strategy yields. The Apple Watch (AW) is a wristwatch able to monitor a wearer's heart rate and rhythm regularity and facilitates real- time, single-lead ECG recordings. This over-the-counter, non-invasive device has demonstrated feasibility and has a Certification (CE) Mark for detecting AF. It may offer a potential non-invasive alternative long-term rhythm surveillance strategy to diagnose AF in these patients. The investigators propose a study in which CS patients will be randomised in a 1:1 ratio to receive additional AW monitoring on top of standard care versus standard care alone. The investigators shall then explore the incidence of AF in the two groups at 1 year and how it impacts clinical outcomes too.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05007847
- 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.
- NCT05016791 — Apple Watch-led Surveillance of AF Recurrence After Catheter Ablation · NA · completed
Other recruiting trials for Cryptogenic Stroke
Currently open trials in the same condition.
- NCT05907694 — Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure · NA · recruiting
- NCT05774288 — Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders. · NA · recruiting
- NCT05565781 — Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke · NA · recruiting
- NCT04881578 — Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study · active not recruiting
- NCT04075084 — Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs) · 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 NCT05007847 (US National Library of Medicine, public domain)
- 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: 25 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/NCT05007847.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing