Paroxysmal Atrial FibrillationSMARTTHUNDERNCT05565781
Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke
A study testing ECG smartwatch, Insertable Cardiac Monitor (ICM) and External ECG Monitoring in people with Paroxysmal Atrial Fibrillation and Cryptogenic Stroke, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (AF) being one of the most important. Prolonged ambulatory cardiac monitoring is recommended for detecting occult AF. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Cryptogenic Stroke
- What is being tested?
- ECG smartwatch, Insertable Cardiac Monitor (ICM) and External ECG Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 28 Mar 2022to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater to or equal to 55 years
- Patients with diagnosis of cryptogenic stroke after a basic study that included neuroimaging, extra/intracranial vascular evaluation, 24-hour monitoring, and echocardiogram
- Patients with acute cortical infarction with the presence of intracranial occlusion (preferably)
- Modified Rankin Scale (mRS) lower to 4
Who cannot join
- Diagnosis of lacunar infarction or transient ischemic attack (TIA)
- Diagnosis of stroke of known source: atherothrombotic due to moderate or severe symptomatic extra/intracranial stenosis, major cardioembolic cause (atrial fibrillation, anterior or apical ventricular akinesis, causal PFO, post-AMI, flutter or mitral stenosis), unusual cause (thrombophilia, arterial dissection symptomatic, toxic)
- Use of pacemakers
- Circumstances that may preclude the clinical follow-up or reduce the possibilities of obtaining data to achieve the objectives of the study and/or limit contact with the investigator (for example, transfer to a social health center)
- Unwillingness to the use of cardiac monitoring wearable devices
- Not understanding study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, 08035
Jorge Pagola, Neurologist, 932746000 ext. 6364, jpagola@vhebron.net
Jorge Pagola, Neurologist
About this study
Official title: Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
Stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (AF) being one of the most important. Prolonged ambulatory cardiac monitoring is recommended for detecting occult AF. Currently, there are non-invasive monitoring devices such as the textile Holter that have proven to be useful for monitoring for up to 30 days but not longer. Another alternative is smartwatches, although they must be validated for use in the elderly population who have had a stroke.
Read the detailed description
The primary objective is to demonstrate that the protocol of ambulatory cardiac monitoring with wearable devices for 12 months allows detection of a higher percentage of occult AF than monitoring for 30 days. The secondary objectives will be to demonstrate the internal validity of smartwatches against insertable cardiac recorders for the detection of AF. To evaluate the usability and adherence to the use of smartwatches in patients with stroke. Detect predictors that can help detect long-term occult AF. Determine the profile of vascular events in each group. Detect predictors of vascular recurrence defined as stroke recurrence, incidence of cerebral hemorrhage, heart failure, myocardial infarction or vascular death.
- Conditions
- Paroxysmal Atrial Fibrillation, Cryptogenic Stroke
- Being tested
- ECG smartwatch, Insertable Cardiac Monitor (ICM), External ECG Monitoring
- Keywords
- Wearable Electronic Devices
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG smartwatchDevice
Testing ECG smartwatch to detect AF or potential signs of AF
Insertable Cardiac Monitor (ICM)Device
Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch)
External ECG MonitoringDevice
Regular cardiac monitor for diagnosis of AF
| Study group | Role | What they receive |
|---|---|---|
| ECG Smartwatch for up to 1 year | Active comparator | Cardiac monitoring with a smartwatch that support the recording of a single-lead electrocardiogram (ECG) over 1 year after the acute phase of cryptogenic stroke. Simultaneously, a continuous cardiac monitoring will be performed using an Insertable Cardiac Monitor (ICM) Receives: Device: ECG smartwatch; Device: Insertable Cardiac Monitor (ICM) |
| Holter monitoring for up to 1 year | Active comparator | Cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke and 15 additional days of extended use every 3 months up to 1 year Receives: Device: External ECG Monitoring |
| Control group | Other | Regular cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke Receives: Device: External ECG Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased probability of detecting AF
To identify and compare prevalence rates of AF detection for the purpose of determine the clinical relevance or not of a prolonged screening process for AF. On the intervention group, patients will have a cardiac monitoring for up to 12 months. If AF is detected by ECG smartwatch, the ICM data will be analyzed by a cardiologist team and provide an ECG report to investigators in order to confirmed ECG smartwatch result.
Measured: Assessed throughout 1 year trial period
Secondary outcomes (5)
Identification of Atrial Fibrillation using a ECG smartwatch
Episodes of atrial fibrillation detected by the ECG smartwatch will be compared to the gold-standard cardiac monitor
Measured: Assessed throughout 1 year trial period
Usability and adherence to ECG Smartwatch
To evaluate the usability to the use of the ECG Smartwatch through the System usability scale (SUS) and self-reported of likes or dislikes encountered with wearable.
Measured: Assessed throughout 1 year trial period
Control of vascular risk factors (VRF)
To describe and compare the percentage of adequate control of VRFs among patients in each study group. VRFs metrics are defined according to the American Heart Association's recommendations, including blood pressure, lipids, glucose, body mass index, nicotine exposure, diet, physical activity, and sleep health. Sub-study analysis will be perform considering data from smartwatch such as sleep, physical activity, and other health behavior.
Measured: Assessed at the end of the 1 and 2 year trial period
Vascular events incidence
To describe the vascular events defined as recurrence of stroke, the incidence of cerebral hemorrhage, heart failure, myocardial infarction, or vascular death in each study group
Measured: Assessed at the end of the 1 and 2 year trial period
Predictors of vascular recurrence
To identify predictors of vascular recurrence (recurrent stroke, cerebral hemorrhage, heart failure, myocardial infarction, or vascular death) in each study group. Predictors of vascular recurrence included sociodemographic data such as age, sex and education level; BMI (kg/m2); history of diabetes mellitus; LDL-cholesterol and medications, such as the use of anti-hypertensive medications, lipid-lowering medications, and antiplatelet therapy. Also clinical symptoms, neuroimagen and ECG parameters will be included in the analysis.
Measured: Assessed at the end of the 1 and 2 year trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start28 Mar 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565781
- Sponsor's protocol ID
- PI20/01210
- Acronym
- SMARTTHUNDER
- Status last verified
- Apr 2025
- First submitted
- 21 Sep 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
- ClinicalTrials.gov ID
- NCT05565781
- Acronym / sponsor ID
- SMARTTHUNDER / PI20/01210
- Conditions
- Paroxysmal Atrial Fibrillation, Cryptogenic Stroke
- Keywords
- Wearable Electronic Devices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 4 Oct 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.
Stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (AF) being one of the most important. Prolonged ambulatory cardiac monitoring is recommended for detecting occult AF. Currently, there are non-invasive monitoring devices such as the textile Holter that have proven to be useful for monitoring for up to 30 days but not longer. Another alternative is smartwatches, although they must be validated for use in the elderly population who have had a stroke.
Detailed description
The primary objective is to demonstrate that the protocol of ambulatory cardiac monitoring with wearable devices for 12 months allows detection of a higher percentage of occult AF than monitoring for 30 days. The secondary objectives will be to demonstrate the internal validity of smartwatches against insertable cardiac recorders for the detection of AF. To evaluate the usability and adherence to the use of smartwatches in patients with stroke. Detect predictors that can help detect long-term occult AF. Determine the profile of vascular events in each group. Detect predictors of vascular recurrence defined as stroke recurrence, incidence of cerebral hemorrhage, heart failure, myocardial infarction or vascular death.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECG Smartwatch for up to 1 year | Active comparator | Device: ECG smartwatch, Device: Insertable Cardiac Monitor (ICM)Cardiac monitoring with a smartwatch that support the recording of a single-lead electrocardiogram (ECG) over 1 year after the acute phase of cryptogenic stroke. Simultaneously, a continuous cardiac monitoring will be performed using an Insertable Cardiac Monitor (ICM) |
| Holter monitoring for up to 1 year | Active comparator | Device: External ECG MonitoringCardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke and 15 additional days of extended use every 3 months up to 1 year |
| Control group | Other | Device: External ECG MonitoringRegular cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater to or equal to 55 years
- Patients with diagnosis of cryptogenic stroke after a basic study that included neuroimaging, extra/intracranial vascular evaluation, 24-hour monitoring, and echocardiogram
- Patients with acute cortical infarction with the presence of intracranial occlusion (preferably)
- Modified Rankin Scale (mRS) lower to 4
Key exclusion criteria (6 listed)
- Diagnosis of lacunar infarction or transient ischemic attack (TIA)
- Diagnosis of stroke of known source: atherothrombotic due to moderate or severe symptomatic extra/intracranial stenosis, major cardioembolic cause (atrial fibrillation, anterior or apical ventricular akinesis, causal PFO, post-AMI, flutter or mitral stenosis), unusual cause (thrombophilia, arterial dissection symptomatic, toxic)
- Use of pacemakers
- Circumstances that may preclude the clinical follow-up or reduce the possibilities of obtaining data to achieve the objectives of the study and/or limit contact with the investigator (for example, transfer to a social health center)
- Unwillingness to the use of cardiac monitoring wearable devices
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 |
|---|---|---|
| ECG smartwatchTesting ECG smartwatch to detect AF or potential signs of AF | Device | ECG Smartwatch for up to 1 year |
| Insertable Cardiac Monitor (ICM)Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch) | Device | ECG Smartwatch for up to 1 year |
| External ECG MonitoringRegular cardiac monitor for diagnosis of AF | Device | Control group, Holter monitoring for up to 1 year |
Primary outcome
Increased probability of detecting AF
Time frame: Assessed throughout 1 year trial period
To identify and compare prevalence rates of AF detection for the purpose of determine the clinical relevance or not of a prolonged screening process for AF. On the intervention group, patients will have a cardiac monitoring for up to 12 months. If AF is detected by ECG smartwatch, the ICM data will be analyzed by a cardiologist team and provide an ECG report to investigators in order to confirmed ECG smartwatch result.
5 secondary outcomes
Identification of Atrial Fibrillation using a ECG smartwatch
Time frame: Assessed throughout 1 year trial period
Usability and adherence to ECG Smartwatch
Time frame: Assessed throughout 1 year trial period
Control of vascular risk factors (VRF)
Time frame: Assessed at the end of the 1 and 2 year trial period
Vascular events incidence
Time frame: Assessed at the end of the 1 and 2 year trial period
Predictors of vascular recurrence
Time frame: Assessed at the end of the 1 and 2 year trial period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG smartwatch, Insertable Cardiac Monitor (ICM) and External ECG Monitoring in people with Paroxysmal Atrial Fibrillation and Cryptogenic Stroke, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased probability of detecting AF (time frame: Assessed throughout 1 year trial period). 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 4 Apr 2025.