Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000863831
Ethics application status
Approved
Date submitted
16/11/2020
Date registered
5/07/2021
Date last updated
25/10/2022
Date data sharing statement initially provided
5/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Smart Wars II: Withings ScanWatch versus Implantable Loop Recorder for Diagnosing Atrial Fibrillation after Unexplained Stroke
Scientific title
Smart Wars II: Withings ScanWatch versus Implantable Loop Recorder for Diagnosing Atrial Fibrillation after Unexplained Stroke
Secondary ID [1] 302806 0
None
Universal Trial Number (UTN)
Trial acronym
Smart Wars II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cryptogenic stroke 319767 0
Atrial fibrillation 319768 0
Condition category
Condition code
Stroke 317701 317701 0 0
Ischaemic
Cardiovascular 319986 319986 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319084 0
Diagnosis / Prognosis
Intervention code [2] 320831 0
Treatment: Devices
Comparator / control treatment
The control treatment will be in the insertion of an implantable loop recorder, which is the standard of care for patients with cryptogenic stroke.

The implantable loop recorder will be inserted by the treating cardiologist.

The loop recorder will remain in place until the battery expires or until atrial fibrillation is detected.

All recruited patient will receive both an Withings ScanWatch and an implantable loop recorder simultaneously.
Control group
Active

Outcomes
Primary outcome [1] 325742 0
Primary outcome 1: Time to new AF diagnosis

This will be assessed using data derived from the Withings ScanWatch
Timepoint [1] 325742 0
The primary time point is 2 years post the initiation of the intervention.
Primary outcome [2] 328146 0
Primary outcome 2: Rate of AF diagnosis of the Withings ScanWatch

This will be assessed using data derived from the Withings ScanWatch
Timepoint [2] 328146 0
The primary time point is 2 years post the initiation of the intervention.
Secondary outcome [1] 388960 0
Secondary outcome 1: Detection of atrial fibrillation using the implantable loop recorder
Timepoint [1] 388960 0
The secondary time point is 2 years post the initiation of the intervention
Secondary outcome [2] 397830 0
Secondary outcome 2: Detection of atrial fibrillation using 24 hour Holter monitoring
Timepoint [2] 397830 0
This secondary time point is identified at the end of 24-hour Holter monitoring

Eligibility
Key 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)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis will be undertaken on an intention-to-treat analysis. Descriptive statistics (means, standard deviation, medians and interquartile ranges will be used to summarise the data. Relationships between variables will be examined using Chi-square tests for categorical data and independent t test or Mann-Whitney rank sum tests for continuous data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/07/2021
Actual
11/10/2021
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
30
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18036 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 32013 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 307232 0
Hospital
Name [1] 307232 0
Eastern Health Foundation Grant
Country [1] 307232 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
8 Arnold Street, Box Hill, VIC, 3128
Country
Australia
Secondary sponsor category [1] 307837 0
None
Name [1] 307837 0
Address [1] 307837 0
Country [1] 307837 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307328 0
Eastern Health HREC
Ethics committee address [1] 307328 0
Ethics committee country [1] 307328 0
Australia
Date submitted for ethics approval [1] 307328 0
13/11/2020
Approval date [1] 307328 0
16/06/2021
Ethics approval number [1] 307328 0
E20-027-70663

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106850 0
A/Prof Andrew Teh
Address 106850 0
Cardiologist & Electrophysiologist
8 Arnold Street, Box Hill Hospital
Box Hill Victoria 3128
Country 106850 0
Australia
Phone 106850 0
+61419306761
Fax 106850 0
Email 106850 0
[email protected]
Contact person for public queries
Name 106851 0
Kevin Rajakariar
Address 106851 0
Cardiology Registrar
8 Arnold Street, Box Hill Hospital
Box Hill, Victoria 3128
Country 106851 0
Australia
Phone 106851 0
+61419306761
Fax 106851 0
Email 106851 0
[email protected]
Contact person for scientific queries
Name 106852 0
Kevin Rajakariar
Address 106852 0
Cardiology Registrar
8 Arnold Street, Box Hill Hospital
Box Hill, Victoria 3128
Country 106852 0
Australia
Phone 106852 0
+61419306761
Fax 106852 0
Email 106852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.