None listed
Conditions
Brief summary
Atrial fibrillation (AF) is one of the leading preventable causes of ischemic strokes worldwide. Screening for AF in post-stroke populations is widely recognised as standard care, however given the paroxysmal and often asymptomatic nature of the disease it can be easily missed using standard 24 hour Holter monitoring. A higher rate of diagnosis can be achieved using longer-term implantable loop recorders (ILRs), but these are invasive and resource-intensive. Withings ScanWatches have the ability, via photoplethysmography (PPG), to continuously monitor heart rate and rhythm and may be a potentially useful diagnostic tool for detecting AF on a larger scale. Furthermore, Withings watches’ new built-in ECG promises to significantly improve accuracy of diagnosis when used in conjunction with PPG. Some previous studies have investigated the usefulness of Withings Watches in diagnosing AF, however no studies have investigating their usefulness utilising this new ECG feature in a post stroke population. Our study hypothesis is to investigate whether the Withings ScanWatch detects atrial fibrillation (an abnormal rhythm which can cause stroke) as effectively as an implantable loop recorder.
Interventions
The Withings ScanWatch is to be worn continuously for 2 years, except when being charged, or until atrial fibrillation is detected. Education will be provided by the cardiologist on how to use the device, and how to electronically send ECG rhythms as per the study protocol. The duration and fitting of the device will take approximately 1 hour. All participants will have usual follow-up with a neurologist. An implantable loop recorder will be inserted using local anaesthetic, under the skin on th
The Withings ScanWatch is to be worn continuously for 2 years, except when being charged, or until atrial fibrillation is detected. Education will be provided by the cardiologist on how to use the device, and how to electronically send ECG rhythms as per the study protocol. The duration and fitting of the device will take approximately 1 hour. All participants will have usual follow-up with a neurologist. An implantable loop recorder will be inserted using local anaesthetic, under the skin on the left side of the chest. Antibiotics will be administered intravenously prior to insertion of the implantable loop recorder. Participants will require a period of fasting prior to the procedure. All participants will be requested to record and email Withings ScanWatch recordings each day for the first 30 days, then twice weekly for the duration of the study in addition to any recordings prompted by device based detection of irregular heart rates notified as “possible atrial fibrillation”. In addition, the information from the implantable loop recorder downloaded routinely every 6 months to the cardiology device clinic. Participants will also be given a remote transmitter to take home, which will automatically send any possible abnormal rhythms detected between these 6 monthly visits. All patients will receive a Patient Information and Consent Form, and a booklet containing step by step instructions in obtaining and emailing a Withings ScanWatch derived ECG. This booklet has been designed specifically for this study. The implantable loop recorder will be inserted by the treating cardiologist, and the Withings ScanWatch will be applied by a doctor involved in the research study. If a 24-hour Holter monitor has not been performed, this will be organised prior to enrolment into the study. Adherence will be monitored during regular clinic visits and ensuring Withings ScanWatch ECGs are emailed as per protocol. As the study is non-randomised, all participants will be allocated to receive both the intervention (Withings ScanWatch) and control treatment (Implantable loop recorder) at the same time.
Sponsors
Eastern Health
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Recent episode (<60 days) of cryptogenic symptomatic TIA or recent episode of ESUS. • A stroke/TIA is considered to be ESUS if no possible cause can be determined despite extensive workup according to the standard protocol of the participating centre. • The following tests are minimally required as standard tests to establish the diagnosis of cryptogenic stroke: • MRI or CT brain • 12-lead ECG for AF detection • 24-h ECG monitoring for AF detection and Holter • Transthoracic echocardiogram • CTA or MRA of head and neck to rule out other causes of stroke pathologies 2. Patient or legally authorized representative is willing to sign patient consent form 3. Patient is > 55 years old with at least one other vascular risk factor (Hypertension, Diabetes, Heart Failure, previous coronary artery or peripheral vascular disease, previous stroke and obesity)
Exclusion criteria
1. Patient has known aetiology of the TIA or stroke (based on neuro-/cardiac/vascular imaging), such as: • Angiographic signs of large-artery atherosclerosis (MRA, CTA, or digital subtraction angiography) in the artery feeding the acute ischemic territory • Radiographic appearance consistent with acute small-artery occlusion, with lesion b1 cm in diameter (DWI or CT). • Evidence of a high-risk cardiac or aortic arch source of embolism (LV or LA thrombus or “smoke,” emboligenic valvular lesion or tumour, PFO with source of venous thromboembolism, aortic arch plaque N3 mm thick or with mobile components or any other high-risk lesion) • History of spontaneous DVT • Stroke of other determined cause such as presence of nonatherosclerotic vasculopathies, hypercoagulable states (must be tested in patients <55 years old) and haematological disorders 2. Patient has untreated hyperthyroidism. 3. Patients had myocardial infarction <1 month before stroke/TIA. 4. Patient had coronary bypass grafting <1 month before stroke/TIA. 5. Patient has valvular disease requiring immediate surgical intervention. 6. Patient has documented history of AF or atrial flutter. 7. Patient has presence of a PFO, and PFO is/was an indication to start OAC in the patient according to the ESO guidelines. 8. Patient has permanent indication for anticoagulation at enrolment. 9. Patient has permanent OAC contraindication. 10. Patient is already included in another clinical trial that will affect the objectives of this study. 11. Patient's life expectancy is <1 year. 12. Patient is pregnant. 13. Patient is indicated for implant with a pacemaker, ICD, CRT device, or an implantable hemodynamic monitoring system 14. Patient is not fit, or is unable or unwilling to follow the required procedures of the Clinical Investigation Plan.
Outcome results
None listed