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

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 26, 2021

Primary Completion Date

August 4, 2022

Study Completion Date

June 15, 2023

Conditions
Atrial Fibrillation
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (1)

OX89DU

Oxford Univeristy Hospitals NHS Foundation Trust, Oxford

All Listed Sponsors
lead

Oxford University Hospitals NHS Trust

OTHER

NCT05207150 - Continuous Rhythm Monitoring With Implantable Cardiac Monitors And Wearable Devices With Real-time Smartphone Alerts During AF Episodes | Biotech Hunter | Biotech Hunter