Atrial FibrillationSMART-ALERTNCT05207150
Continuous Rhythm Monitoring With Implantable Cardiac Monitors And Wearable Devices With Real-time Smartphone Alerts During AF Episodes
A study testing LINQII/Apple Watch Series 6 and LINQII/SkyLabs CART-I ring in people with Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- LINQII/Apple Watch Series 6 and LINQII/SkyLabs CART-I ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2021to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Univeristy Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX89DU
About this study
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.
Read more
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
- Being tested
- LINQII/Apple Watch Series 6, LINQII/SkyLabs CART-I ring
- Keywords
- AF, Apple Watch, CART-I ring, LINQ II, Wearable
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINQII/Apple Watch Series 6Device
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 ringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| LINQ II/Apple Watch Series 6 | Active comparator | Not described Receives: Device: LINQII/Apple Watch Series 6 |
| LINQII/SkyLabs CART-I ring | Active comparator | Not described Receives: Device: LINQII/SkyLabs CART-I ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Apple Watch and Skylabs CART-I ring diagnostic accuracy for AF episodes longer than 30 minutes compared to the LINQ II™ ICM (gold standard).
Measured: 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.
Percentage of successful alerts sent by the Apple Watch and Skylabs CART-I ring.
Measured: During follow-up (6 months)
To study participants' compliance wih the Apple Watch and the Skylabs CART-I ring
Percentage of time the wearable devices have been used and comparison between different modalities will be calculated.
Measured: During follow-up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start26 Nov 2021
- Primary completion4 Aug 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust
- Investigators
- Tim Betts, MD MBChB FRCP, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207150
- Sponsor's protocol ID
- 15634
- Acronym
- SMART-ALERT
- Status last verified
- Aug 2023
- First submitted
- 12 Dec 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Rhythm Monitoring With Implantable Cardiac Monitors And Wearable Devices With Real-time Smartphone Alerts During AF Episodes
- ClinicalTrials.gov ID
- NCT05207150
- Acronym / sponsor ID
- SMART-ALERT / 15634
- Conditions
- Atrial Fibrillation
- Keywords
- AF, Apple Watch, CART-I ring, LINQ II, Wearable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LINQII/Apple Watch Series 6LINQ 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 | LINQ II/Apple Watch Series 6 |
| LINQII/SkyLabs CART-I ringLINQ 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. | Device | LINQII/SkyLabs CART-I ring |
Primary outcome
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
Time frame: During follow-up (6 months)
Percentage of successful alerts sent by the LINQII™ ICM.
3 secondary outcomes
To study the diagnostic accuracy of the Apple Watch and the Skylabs CART-I ring in the detection of AF episodes .
Time frame: 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.
Time frame: During follow-up (6 months)
To study participants' compliance wih the Apple Watch and the Skylabs CART-I ring
Time frame: During follow-up (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Betts, MD MBChB FRCP principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LINQII/Apple Watch Series 6 and LINQII/SkyLabs CART-I ring in people with Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: During follow-up (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.