Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 7:04 AM
Study NCT ID:
NCT05207150
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2021-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Rhythm Monitoring With Implantable Cardiac Monitors And Wearable Devices With Real-time Smartphone Alerts During AF Episodes
Sponsor:
Oxford University Hospitals NHS Trust
Organization:
Study Overview
Official Title:
Continuous Rhythm Monitoring With Implantable Cardiac Monitors And Wearable Devices With Real-time Smartphone Alerts During AF Episodes
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-ALERT
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: