Continuous Rhythm Monitoring With Implantable Cardiac Monitors And Wearable Devices With Real-time Smartphone Alerts During AF Episodes
NCT ID: NCT05207150
Last Updated: 2023-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2021-11-26
2023-06-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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LINQ II/Apple Watch Series 6
LINQII/Apple Watch Series 6
LINQ II will be implanted and in the first 3 months it will send alerts to participants' smartphones if it detects an AF episode longer than 30 minutes. After 3 months, participants will wear an Apple Watch Series 6 for another 3 months. The LINQ II ICM will continue to detect and record AF episodes and will be used to validate the AF detection accuracy by the wearable devices but it will no longer send alerts during AF episodes. Instead, the wearable device (Apple Watch) will send a real-time alert to participants during AF episodes longer than 30 minutes and participants will use the appropriate smartphone app to acknowledge they have received the alert.
LINQII/SkyLabs CART-I ring
LINQII/SkyLabs CART-I ring
LINQ II will be implanted and in the first 3 months it will send alerts to participants' smartphones if it detects an AF episode longer than 30 minutes. After 3 months, participants will wear a SkyLabs CART-I ring for another 3 months. The LINQ II ICM will continue to detect and record AF episodes and will be used to validate the AF detection accuracy by the wearable devices but it will no longer send alerts during AF episodes. Instead, the wearable device (CART-I ring) will send a real-time alert to participants during AF episodes longer than 30 minutes and participants will use the appropriate smartphone app to acknowledge they have received the alert.
Interventions
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LINQII/Apple Watch Series 6
LINQ II will be implanted and in the first 3 months it will send alerts to participants' smartphones if it detects an AF episode longer than 30 minutes. After 3 months, participants will wear an Apple Watch Series 6 for another 3 months. The LINQ II ICM will continue to detect and record AF episodes and will be used to validate the AF detection accuracy by the wearable devices but it will no longer send alerts during AF episodes. Instead, the wearable device (Apple Watch) will send a real-time alert to participants during AF episodes longer than 30 minutes and participants will use the appropriate smartphone app to acknowledge they have received the alert.
LINQII/SkyLabs CART-I ring
LINQ II will be implanted and in the first 3 months it will send alerts to participants' smartphones if it detects an AF episode longer than 30 minutes. After 3 months, participants will wear a SkyLabs CART-I ring for another 3 months. The LINQ II ICM will continue to detect and record AF episodes and will be used to validate the AF detection accuracy by the wearable devices but it will no longer send alerts during AF episodes. Instead, the wearable device (CART-I ring) will send a real-time alert to participants during AF episodes longer than 30 minutes and participants will use the appropriate smartphone app to acknowledge they have received the alert.
Eligibility Criteria
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Inclusion Criteria
* Male or Female aged 18 years or above.
* Paroxysmal AF with symptoms, Holter recording and/or implantable device evidence of \>1 but \<15 episodes of AF in the last 3 months.
* Persistent AF scheduled for repeat cardioversion (i.e. having had at least one prior cardioversion).
* Currently have an Apple IOS or Android smartphone.
Exclusion Criteria
* Contra-indications for implantable cardiac monitor.
* Visual or physical impairment that prevents ability to read and acknowledge smartphone/watch notifications.
* Unable to comply with the follow-up schedule.
* Do not have Apple IOS or android smartphone.
18 Years
ALL
No
Sponsors
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Oxford University Hospitals NHS Trust
OTHER
Responsible Party
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Tim Betts MD MBChB FRCP
Primary Investigator
Principal Investigators
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Tim Betts, MD MBChB FRCP
Role: PRINCIPAL_INVESTIGATOR
Oxford University Hospitals NHS Trust
Locations
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Oxford Univeristy Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
Countries
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Other Identifiers
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15634
Identifier Type: -
Identifier Source: org_study_id
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