Atrial FibrillationSCREEN-AFNCT02392754
Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older
A study testing Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP) in people with Atrial Fibrillation and Hypertension, run by Population Health Research Institute at 28 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Hypertension
- What is being tested?
- Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 856 participants
- Where
- 28 sitesin 2 countries
- Study dates
- 1 Apr 2015to 21 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
Canada25 sites
Henry Vlaar FP
Ayr, Ontario, N0B 1E0
LMC / Manna Research
Burlington, Ontario, L7R 1E2
Crowfoot Village Family Practice
Calgary, Alberta, T3G 0B4
Smith Clinic
Camrose, Alberta
Edmonton Oliver PCN
Edmonton, Alberta, T5H 3V9
Humber River FHT - Dixon Site
Etobicoke, Ontario, M9P
Halton Hills FHT
Georgetown, Ontario, L7G 4A1
Haileybury FHT
Haileybury, Ontario, P0J 1K0
Hamilton Medical Clinic
Hamilton, Ontario, L8J 0B6
Queen's Family Health Team
Kingston, Ontario, K7L 5E9
Ken Ng FP / Total Health Management
Markham, Ontario, L3P 5T7
St. Lawrence Medical Clinic
Morrisburg, Ontario, K0C 1X0
SKDS Research Inc.
Newmarket, Ontario, L3Y 5G8
OakMed FHT
Oakville, Ontario, L6H 7S8
Peaks to Praries PCN
Olds, Alberta, T4H 1B8
Mark Robertson Family Practice
Owen Sound, Ontario, N4K 4K8
Garden City FHT
Saint Catherines, Ontario, L2R 1R5
Michael Kopp Family Practice / N Fung & M Kopp Medicine Professional Corporation
St. Catharines, Ontario, L2N 4V5
Health for All FHT
Stouffville, Ontario, L6B 0T1
Port Arthur Health Centre
Thunder Bay, Ontario, P7A 4V7
Keele Medical Place
Toronto, Ontario, M3M 3E5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Women's College Hospital
Toronto, Ontario, M5S 1B2
Mount Dennis Weston Health Centre
Toronto, Ontario, M6N 4N6
Sameh Fikry Medicine Professional Corporation
Waterloo, Ontario, N2J 1C4
Germany3 sites
Goethe University Frankfurt am Main
Frankfurt am Main
Universitätsmedizin Göttingen
Göttingen
Hamburg University Medical School
Hamburg
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation, Hypertension
- Being tested
- Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)
- Keywords
- Screening, Atrial Fibrillation, ECG, Primary care
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)Device
Also called ZIO XT Patch ambulatory ECG patch monitor, Watch BP-Home A blood pressure monitor
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening | Experimental | 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. Receives: Device: Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP) |
| Control | No intervention | The control group receives standard care for 6 months (including a pulse check and heart auscultation by a physician at 6 months). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 6 month from randomization
Secondary outcomes (8)
Prescription of oral anticoagulation therapy
Oral anticoagulant therapy use at 3 and 6 months post-randomization.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: within 6 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start1 Apr 2015
- Primary completion21 Oct 2019
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- 856 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Stroke Prevention Intervention Network, Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Canadian Stroke Network, iRhythm Technologies, Inc., Microlife, University of Leipzig, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Sponsor
- Investigators
- David J. Gladstone, MD PhD FRCPC, Principal investigator, Sunnybrook Research Institute, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392754
- Sponsor's protocol ID
- SCREEN-AF
- Acronym
- SCREEN-AF
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038.
PubMed 33625468
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02392754
- Acronym / sponsor ID
- SCREEN-AF / SCREEN-AF
- Conditions
- Atrial Fibrillation, Hypertension
- Keywords
- Screening, Atrial Fibrillation, ECG, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 856 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Stroke Prevention Intervention Network, Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Canadian Stroke Network, iRhythm Technologies, Inc., Microlife, University of Leipzig, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 19 Mar 2015 (estimated)
- 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.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening | Experimental | Device: Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)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. |
| Control | No intervention | –The control group receives standard care for 6 months (including a pulse check and heart auscultation by a physician at 6 months). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)Also: ZIO XT Patch ambulatory ECG patch monitor, Watch BP-Home A blood pressure monitorThe 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 |
Primary outcome
Detection of new atrial fibrillation or flutter
Time frame: within 6 month from randomization
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.
8 secondary outcomes
Prescription of oral anticoagulation therapy
Time frame: within 6 months from randomization
Primary endpoint detected by ECG patch monitor
Time frame: 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)
Time frame: within 6 months from randomization
Adherence, tolerability and patient satisfaction with screening devices
Time frame: within 6 months of randomization
Clinical outcome events
Time frame: within 6 months from randomization
Cost effectiveness of screening
Time frame: within 6 months from randomization
Detection of other (non-AF) clinically important arrhythmias
Time frame: 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).
Time frame: within 6 months from randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 33625468Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038.
- This website explains the SCREEN AF study and the C-SPIN networkLink provided by the sponsor.
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Atrial Fibrillation (AF)
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. This study is not recruiting at the moment.
David J. Gladstone, MD PhD FRCPC principal investigator
Sunnybrook Research Institute, University of Toronto
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP) in people with Atrial Fibrillation and Hypertension, run by Population Health Research Institute at 28 sites in 2 countries.
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: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Canada, Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of new atrial fibrillation or flutter (time frame: within 6 month from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392754, which also lists 1 linked publication.
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 27 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.