Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is a major treatable risk factor for stroke, but it may be hard to detect because it is frequently silent and intermittent. New ambulatory cardiac monitoring technologies have the potential to improve early detection of AF. This trial investigates AF screening in primary care patients using the ZIO XT Patch, a wearable adhesive patch monitor that provides continuous ECG recording for up to 14 days, in addition to the WatchBP home blood pressure monitor that has built-in AF screening capability.

Detailed Description
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SCREEN-AF is an investigator-initiated, multicenter, open-label, two-group randomized controlled trial investigating non-invasive, home-based AF screening. The trial targets patients aged 75 years or older with a history of hypertension and without known AF who would be potential anticoagulant candidates if AF were detected. Eligible participants will be recruited from primary care practices and randomly allocated (1:1) to one of two groups: The control group will receive standard care for 6 months (including a pulse check and heart auscultation by a physician at baseline and 6 months). The intervention group will undergo ambulatory screening for AF with a 2-week continuous ECG patch monitor worn at baseline and again at 3 months, in addition to standard care for 6 months (including a pulse check and heart auscultation by a physician at baseline and 6 months). The intervention group will also receive a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring blocks. The hypothesis is that continuous ambulatory cardiac rhythm monitoring using an adhesive ECG patch monitor will be superior to standard care for AF detection. The overall aim of this research is to establish a practical and cost-effective screening strategy that could be applied in primary care for early detection of AF in patients who would benefit from anticoagulant therapy if AF were detected. The ultimate goal of this primary prevention initiative is to prevent more strokes, and stroke-related deaths, disability, dementia, hospitalizations and institutionalization, through the early detection and treatment of AF.

Official Title
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Program for Identification of Actionable Atrial Fibrillation (PIAAF): Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older: the SCREEN-AF Randomized Trial

Conditions
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Atrial Fibrillation, Hypertension

Intervention / Treatment
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* Device: Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥75 years without known atrial fibrillation or atrial flutter. The participant is clinically in sinus rhythm (both heart auscultation and 30- second pulse palpation have been performed by the enrolling physician and neither detects an irregular rhythm suggestive of atrial fibrillation). History of hypertension requiring antihypertensive medication. Written informed consent from the participant. Exclusion Criteria: Any previously documented atrial fibrillation or atrial flutter ≥30 seconds. Implanted pacemaker, cardiac defibrillator, cardiac loop recorder, or deep brain stimulator. Likely to be poorly compliant or unreliable using home screening devices or with study follow-up requirements because of cognitive or other issues, or life expectancy <6 months due to concomitant disease. Has a condition which in the opinion of the enrolling physician would not permit chronic treatment with oral anticoagulant therapy. Patient already taking long-term oral anticoagulant therapy. Known allergic reaction/intolerance to skin adhesives.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening<br>The intervention group receives AF screening with a 2-week ambulatory ECG patch monitor (ZIO XT Patch) worn at baseline and again at 3 months, in addition to standard care for 6 months. The intervention group also receives a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring periods. | Device: Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)<br>* The intervention group receives AF screening with a 2-week ambulatory ECG patch monitor (ZIO XT Patch) worn at baseline and again at 3 months, in addition to standard care for 6 months. The intervention group also receives a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring periods.<br>* Other names: Watch BP-Home A blood pressure monitor;|
| No Intervention: Control<br>The control group receives standard care for 6 months (including a pulse check and heart auscultation by a physician at 6 months). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of new atrial fibrillation or flutter | Detection of new AF (atrial fibrillation or atrial flutter) within 6 months post-randomization, with AF defined as at least one episode of continuous AF lasting >5 minutes or AF documented on at least one 12-lead ECG or a convincing clinical diagnosis of AF based on reliable source documentation. | within 6 month from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription of oral anticoagulation therapy | Oral anticoagulant therapy use at 3 and 6 months post-randomization. | within 6 months from randomization | 
| Primary endpoint detected by ECG patch monitor | Among intervention group patients that meet the primary endpoint, detected by the ECG patch monitor, the following criteria will be analyzed: time to first detection of AF >5 minutes daily and total AF burden average duration per AF episode. | within 6 months from randomization | 
| Atrial fibrillation episodes of various durations (detection of any AF episode ≥30 seconds, ≥30 seconds to 5 minutes, >5 hours, and >24 hours (to facilitate comparison with other studies in the literature) | Among intervention group patients, detection of any AF episode ≥30 seconds, ≥30 seconds to 5 minutes, >5 hours, and >24 hours (to facilitate comparison with other studies in the literature). | within 6 months from randomization | 
| Adherence, tolerability and patient satisfaction with screening devices | This is a composite outcome measured by the following: Patient adherence with the screening devices (defined as the average number of monitoring days completed and reasons for non-adherence) Patient satisfaction with the screening devices (as measured by user satisfaction surveys), - Tolerability of the ECG monitor (defined as the incidence of adverse skin reactions related to the adhesive patch). | within 6 months of randomization | 
| Clinical outcome events | A clinical outcome event will be defined as one of the following: ischemic stroke TIA systemic embolism major bleeding intracranial hemorrhage physician visits hospitalizations medication prescriptions. Clinical outcome events will be captured within 6 months post-randomization. The outcome is a composite measure. | within 6 months from randomization | 
| Cost effectiveness of screening | The cost effectiveness of screening is a composite outcome. The outcome will be measured by cost-effectiveness (cost per life year saved) and cost-utility (cost per quality adjusted life year (QALY) gained) of AF screening. | within 6 months from randomization | 
| Detection of other (non-AF) clinically important arrhythmias | Detection of other potentially clinically important non-AF arrhythmias: atrial tachycardia, pause >3 seconds, high-grade atrioventricular block (Mobitz type II or third-degree AV block), ventricular tachycardia, polymorphic ventricular tachycardia/ventricular fibrillation. | within 6 months from randomization | 
| Sensitivity and specificity of Watch BP Home-A monitor ( false positive rate of a home AF-BP monitor (with ECG patch monitor as the gold standard). | Estimated sensitivity, specificity and false positive rate of a home AF-BP monitor (with ECG patch monitor as the gold standard). | within 6 months from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Atrial Fibrillation, Primary care, ECG