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Atrial Fibrillation (AF)SNAPSNCT07407790

The Southern-Norway Post-Stroke Atrial Fibrillation Study

A study testing Patch ECG in people with Atrial Fibrillation (AF) and Atrial Fibrillation (Prevention of Stroke), run by Sorlandet Hospital HF at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study evaluates whether a procedure using a new wireless heart sensor patch is equal to or better than the standard hospital procedures and equipment at detecting an irregular heartbeat called Atrial Fibrillation (AF) after an ischemic stroke. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patch ECG
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteNorway
Study dates
10 Jan 2026to Dec 2029
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients hospitalized with an ischemic stroke or transient ischemic attack (TIA), including amaurosis fugax, occurring within the last 2 weeks.
  • Initial evaluation of CT and/or CT angiography and/or MRI supports a diagnosis of TIA or ischemic stroke.
  • Available smartphone and access to the ECG247-app to be able to participate in the study.
  • Estimated life span of >6 month
  • Permanent address in Norway
  • Informed Consent, Capable of giving signed informed consent or consent through proxy as described in Appendix which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Medical Conditions
  • Known AF or atrial flutter prior to inclusion
  • Concomitant use of anticoagulation therapy or established contraindication to its use. To date this includes apixaban, rivaroxaban, edoxaban, dabigatran, warfarin and indirect thrombin inhibitors (except for short term thrombosis prevention).
  • Implanted pacemaker, ICD or loop-recorder
  • >70% stenosis of carotid artery on ipsilateral side to the stroke on CT angiography or ultrasound
  • Pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Halvor Oeygarden, PhD contact

+4747621336

halvor.oygarden@sshf.no

Ivana Sapina, PhD student contact

+47 47311701

ivana.sapina@sshf.no

Norway1 site, 1 recruiting
  • Sørlandet Sykehus HF

    Kristiansand, 4615

    Recruiting

Other trials in Norway

About this study

This study evaluates whether a procedure using a new wireless heart sensor patch is equal to or better than the standard hospital procedures and equipment at detecting an irregular heartbeat called Atrial Fibrillation (AF) after an ischemic stroke. Atrial fibrillation is a major cause of stroke, but it can be difficult to catch because it often comes and goes.

The study will include approximately 450 adults who have had a stroke or a transient "mini-stroke" (TIA) within the last two weeks. Participants will be assigned by chance (randomized) to one of two groups:

Read more
  • Group 1 (Intervention): Participants wear the "ECG247 Smart Heart Sensor." This is a small patch that sticks to the chest and connects to a smartphone. It is worn continuously for up to 14 days, even after leaving the hospital.
  • Group 2 (Standard Care): Participants receive the standard hospital check-up. This typically involves using a "Holter monitor" (a device with wires and electrodes) for a period of about 24 to 48 hours some time after leaving the hospital.

The main goal is to see if the procedure using the patch is equal to the standard procedure in detecting atrial fibrillation in participants. The study will also measure how quickly doctors can start the correct medication and how easy the patients find the devices to use.

Read the detailed description

Background and Rationale Atrial fibrillation (AF) is a major risk factor for ischemic stroke, yet it often goes undetected due to its paroxysmal (intermittent) nature. While guidelines recommend prolonged heart rhythm screening after a stroke of undetermined cause, standard hospital practice often relies on short-term telemetry and ambulatory Holter monitoring. These standard methods can be limited by device availability, bulkiness, and short monitoring duration (typically 24-48 hours), potentially leading to under-diagnosis of AF.

This study aims to evaluate the clinical utility and cost-effectiveness of a novel, continuous patch ECG system (ECG247) initiated in the hospital setting compared to standard care.

Study Design This is a prospective, randomized, parallel-group, open-label (no masking) study conducted at a single stroke center. Approximately 450 eligible patients will be enrolled.

Recruitment and Stratification Patients admitted with ischemic stroke or transient ischemic attack (TIA) within the last two weeks are screened for eligibility, aiming for inclusion within 48 hours of admission. Participants are randomized in a 1:1 ratio to either the intervention arm or the standard care arm. Randomization is stratified by age into three groups: 18-64 years, 65-74 years, and ≥75 years.

Intervention Arm (ECG247 Smart Heart Sensor) Patients in this group will have the ECG247 patch applied to the anterior chest wall while in the hospital.

  • Device: The ECG247 is a wireless, water-resistant patch sensor that connects to a dedicated smartphone application via Bluetooth. It transmits data to a secure cloud service for analysis.
  • Duration: The device is worn continuously for up to 14 days. Monitoring begins in-hospital and continues after discharge.
  • Analysis: The system utilizes an algorithm to detect arrhythmia. Episodes of AF >30 seconds are considered positive findings. Study personnel and physicians verify algorithm-detected episodes.
  • Concurrent Care: These patients also receive standard in-house telemetry per hospital protocol while admitted.

Control Arm (Standard Care) Patients in this group receive standard heart rhythm monitoring according to current hospital guidelines.

  • In-hospital: Monitoring via continuous telemetry or intermittent ECGs based on availability and clinical priority.
  • Ambulatory: Upon discharge, patients are referred for ambulatory Holter monitoring. The duration is typically 24-48 hours as decided by the treating cardiologist.
  • Analysis: Holter recordings are analyzed by trained technicians and reviewed by a cardiologist.

Biomarker Analysis Blood samples will be collected from all participants to analyze N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels. The study will assess the association between NT-proBNP levels and the detection of silent AF to evaluate its potential for risk stratification.

Outcomes and Follow-up

  • Primary Outcome: The detection rate of AF (defined as episodes ≥30 seconds).
  • Secondary Outcomes: Time to AF detection, time to initiation of anticoagulation therapy, total monitoring duration, and health economics.
  • User Experience: Patients in the intervention group will complete Patient Reported Experience Measures (PREMs) regarding usability and satisfaction.
  • Long-term Follow-up: Participants will be followed for up to 12 months to assess clinical endpoints, including secondary stroke, TIA, and major bleeding.
Being tested
Patch ECG, Standard Care (in control arm)
Keywords
stroke, atrial fibrillation, anticoagulation
Medical subject headings
Atrial Fibrillation, Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patch ECGDevice

    This study aims to evaluate the clinical utility and cost-effectiveness of a novel, continuous patch ECG system (ECG247) initiated in the hospital setting compared to standard care.

  • Standard Care (in control arm)Device

    Patients in this group receive standard heart rhythm monitoring according to current hospital guidelines.

Study groups in NCT07407790
Study groupRoleWhat they receive
Intervention Arm (ECG247 Smart Heart Sensor)ExperimentalPatients in this group will have the ECG247 patch applied to the anterior chest wall while in the hospital. * Device: The ECG247 is a wireless, water-resistant patch sensor that connects to a dedicated smartphone application via Bluetooth. It transmits data to a secure cloud service for analysis. * Duration: The device is worn continuously for up to 14 days. Monitoring begins in-hospital and continues after discharge. * Analysis: The system utilizes an algorithm to detect arrhythmia. Episodes of AF >30 seconds are considered positive findings. Study personnel and physicians verify algorithm-detected episodes. * Concurrent Care: These patients also receive standard in-house telemetry per hospital protocol while admitted.
Receives: Device: Patch ECG
Control Arm (Standard Care)OtherPatients in this group receive standard heart rhythm monitoring according to current hospital guidelines. * In-hospital: Monitoring via continuous telemetry or intermittent ECGs based on availability and clinical priority. * Ambulatory: Upon discharge, patients are referred for ambulatory Holter monitoring. The duration is typically 24-48 hours as decided by the treating cardiologist. * Analysis: Holter recordings are analyzed by trained technicians and reviewed by a cardiologist.
Receives: Device: Standard Care (in control arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection rate of atrial fibrillation

    The detection rate of AF (defined as episodes ≥30 seconds). Analysis will be performed on an intention-to-treat basis, and AF detection will be primarily assessed for its non-inferiority and secondarily for difference in proportions. An interim analysis for efficacy measures will be performed using the O'Brien-Flemming correction for the primary endpoint AF detection rate after 72 and 144 participants in each arm.

    Measured: From enrollment to the end of heart rate monitoring. Will also be registered on follow up after 12 months.

  2. Time from enrollment to treatment initiation with anticoagulant medicine

    Days from enrollment until AF detection results in change of prophylactic treatment, defined as prescribed anticoagulant medication collected by the patient, retrieved from e-prescription data accessed through the Summary Care Record (Kjernejournal).

    Measured: From enrollment until end of follow up (12 months after enrollment).

  3. Time from enrollment to detection of first AF episode

    Time to detection of first episode of atrial fibrillation after hospital admission

    Measured: From enrollment up to 1 year

  4. Total duration of heart rate monitoring

    Total duration of heart rate monitoring, also including an assessment of device signal quality for assessment

    Measured: From enrollment up to 1 year

  5. Numbers of participants with secondary stroke/TIA and/or major bleeding

    Assessing secondary stroke and major bleeding at 1 year of follow-up

    Measured: From enrollment to one-year follow up, assessed at 1-year follow up.

Secondary outcomes (7)
  1. Explore the practical utility in regards to validity of results of AF screening after a stroke with a patch ECG

    Inter-rater validity of ECG results between the ECG247 algorithm, cardiologists and neurologists

    Measured: After 1 year of recruitment

  2. Explore the practical utility of time consumed using AF screening after a stroke with a patch ECG

    A suitable number of observations will be performed to evaluate the time needed to complete the patch ECG attachment and inform the patient, interpret the results and follow-up of results

    Measured: After 1 year of recruitment

  3. Explore the practical utility and reliability of AF screening after a stroke with a patch ECG

    Reliability of the monitoring device in crude versus interpretable monitoring duration in hours. Reliability will be assessed by the study personnel when creating the patch ECG result record. The whole pulse rate strip will be analyzed to identify periods of 1>h with a lack of signal or reduced signal quality. The total monitoring duration registered by the algorithm in hours versus manual interpretation with readable signal in hours will be evaluated as a percentage: Useable monitoring time/Total monitoring time x 100% = Percentage of useful monitoring.

    Measured: Assessed at 1 year after enrollment start

  4. Explore the practical utility and patient satisfaction of AF screening after a stroke with a patch ECG

    Patient Reported Experience Measures (PREMs) to all patients in interventional arm within a month of discharge and within 1 month of Holter completion for control arm, registration of technical problems, allergic reactions to patch, photo of patch placement and registration of patients not considered eligible to the study due to lack of smartphone and other causes not listed in the exclusion/inclusion criteria. PREMS will be reported by a 7 point Likert scale, with higher values indicating a high level of satisfaction.

    Measured: Through study completion

  5. Diagnostic quality of in-house patch ECG compared to telemetry

    Sensitivity and specificity of AF detection in patch ECG compared to concomitant telemetry.

    Assessment of detection of other dangerous arrhythmias in patch ECG compared to telemetry.

    Quality of signal from telemetry compared to patch ECG. In the subgroup of patients where patch ECG and telemetry are worn simultaneously, the results of both methods will be cross-validated against each other

    Measured: From start of enrollment until discharge of last included patient

  6. Cost effectiveness of patch ECG compared to standard care

    Cost-effectiveness analysis of patch ECG and standard care with the endpoint being reduced secondary stroke

    Measured: From enrollment until end of follow up.

  7. Assess predictors of silent AF

    Association between clinical, radiological and laboratory factors (including) NT-pro-BNP level and AF NT-proBNP will be assessed upon inclusion and can be analyzed from blood samples drawn on day 1 after admission.

    MRI results Echocardiography results CHADSVASC, age, gender, medication used, previous diseases, BMI

    Measured: From enrollment until end of patient follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start10 Jan 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, randomized, parallel-group, open-label (no masking) screening study.
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07407790
Sponsor's protocol ID
REKID 931942
Acronym
SNAPS
Status last verified
Dec 2025
First submitted
25 Jan 2026
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Currently undecided regarding the sharing of IPD. No established formal cooperation agreements with external research groups to date. Any future decision to share data will depend on the establishment of such collaboration agreements in adherence to data protection regulations.

Questions about this trial

What is this clinical trial studying?

A study testing Patch ECG in people with Atrial Fibrillation (AF) and Atrial Fibrillation (Prevention of Stroke), run by Sorlandet Hospital HF at 1 site in Norway.

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 6 inclusion and 7 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 12 Feb 2026. 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 Norway. 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?

Contact Halvor Oeygarden, PhD (+4747621336, halvor.oygarden@sshf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection rate of atrial fibrillation (time frame: From enrollment to the end of heart rate monitoring. Will also be registered on follow up after 12 months.). The study lists 5 primary outcomes in all. 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 12 Feb 2026.

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