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

NCT05207150 | Completed

• 1 other identifier: 15634
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

AF; Apple Watch; CART-I ring; LINQ II; Wearable

Outcome Measures

Primary Outcomes (1)

• To assess the performance of the LINQ II™ ICM in sending real-time alerts to participants' smartphone and to Carelink (physicians web portal) during AF episodes longer than 30 minutes

  Percentage of successful alerts sent by the LINQII™ ICM.

  During follow-up (6 months)

Secondary Outcomes (3)

• To study the diagnostic accuracy of the Apple Watch and the Skylabs CART-I ring in the detection of AF episodes .

  During the follow-up period (6 month)Apple Watch and Skylabs CART-I ring sensitivity, specificity, positive and negative predictive for AF episodes longer than 30 minutes.

• To assess the performance of the Apple Watch and the Skylabs CART-I ring in sending real-time alerts to their smartphone apps and participants' engagement.

  During follow-up (6 months)

• To study participants' compliance wih the Apple Watch and the Skylabs CART-I ring

  During follow-up (6 months)

Study Arms (2)

LINQ II/Apple Watch Series 6

ACTIVE COMPARATOR

Device: LINQII/Apple Watch Series 6

LINQII/SkyLabs CART-I ring

ACTIVE COMPARATOR

Device: LINQII/SkyLabs CART-I ring

Interventions

LINQII/Apple Watch Series 6 DEVICE

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.

LINQ II/Apple Watch Series 6

LINQII/SkyLabs CART-I ring DEVICE

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.

LINQII/SkyLabs CART-I ring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the trial.
• 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.

You may not qualify if:

• Diagnosis of permanent AF.
• 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.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Oxford Univeristy Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX89DU, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tim Betts, MD MBChB FRCP

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 26, 2022
• Study Start: November 26, 2021
• Primary Completion: August 4, 2022
• Study Completion: June 15, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

GB (1)