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NCT05207150: SMART-ALERT

Continuous Rhythm Monitoring With Implantable Cardiac Monitors And Wearable Devices With Real-time Smartphone Alerts During AF Episodes

Completed NA Last updated 8 August 2023
What this trial tests

NA trial testing LINQII/Apple Watch Series 6 in Atrial Fibrillation in 50 participants. Completed in 15 June 2023.

Timeline
26 November 2021
Primary endpoint
4 August 2022
15 June 2023

Quick facts

Lead sponsorOxford University Hospitals NHS Trust
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment50
Start date26 November 2021
Primary completion4 August 2022
Estimated completion15 June 2023
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Oxford University Hospitals NHS Trust

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Atrial fibrillation (AF) is the most common arrhythmia affecting 1.3 million people in the UK. AF causes an irregular and fast heartbeat, which makes the heart pump poorly. As a result, blood clots may form inside the heart and, if they travel to the brain, can lead to an AF-related stroke. Patients with AF have a risk of stroke five-times higher than patients with normal rhythm. Anticoagulants make the blood less likely to clot and, thus, reduce the chances of an AF-related stroke. For most people, once anticoagulation is started it must be taken for the rest of their lives irrespective of the amount of AF someone has. However, anticoagulants make patients more prone to bleeding. New studies have reported a lower stroke risk in patients with short and infrequent AF episodes. If there are long time gaps in between AF episodes, short periods of anticoagulation around the time of AF may be enough to avoid clots from forming and reducing the overall risk of bleeding. To use anticoagulants only when needed will require an accurate and reliable way to detect AF when it occurs and alert patients. New technologies, such as small heart monitors placed under the skin, watches and rings, can track the heart rhythm continuously and send real-time alerts to patients via mobile phone message if AF is detected. The purpose of this study is to investigate if implantable cardiac monitors (LINQ II) and wearable devices (Apple Watch and CART-I ring) can detect AF episodes, send real-time alerts to patients and who will respond to these alerts within a short timeframe. The investigators will recruit 50 patients and follow them for six months. All participants will receive a LINQ II and a wearable device.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 'Pill-in-the-pocket' Oral Anticoagulation Guided by Daily Rhythm Monitoring for Stroke Prevention in Patients with AF: A Systematic Review and Meta-analysis.
    Briosa E Gala A, Pope MTB, Leo M, Sharp AJ, et al · · 2023 · cited 1× · PMID 37600156 · DOI 10.15420/aer.2022.22

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Other recruiting trials for Atrial Fibrillation

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Data sources for this page

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/NCT05207150.

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