Atrial Fibrillation New OnsetSAFE-WNCT05444335
Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years
A study testing Wearable cardiac monitor -Zio patch in people with Atrial Fibrillation New Onset, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Screening for Atrial Fibrillation in Elderly Women (SAFE-W) is a pilot study evaluating the prevalence of atrial fibrillation (Afib) in a rapidly aging segment of the population. Read more about this study
- Who is it for?
- Ages 70 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- Wearable cardiac monitor -Zio patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2023to 15 Dec 2026
- 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 70 to 100 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Female sex
- No previous diagnosis of atrial fibrillation
- Age ≥70 years
- CHA2DS2-VASc score ≥4
Who cannot join
- Life expectancy < 2 years
- Dementia or other neurologic condition which would make outpatient follow-up difficult
- CHA2DS2-VASc score ≤3
- Any compliance issues - such as heavy alcohol/drug use that would impede follow up.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Screening for Atrial Fibrillation in Elderly Women (SAFE-W) is a pilot study evaluating the prevalence of atrial fibrillation (Afib) in a rapidly aging segment of the population. Studies have shown that women with Afib are more likely to be symptomatic, have increased mortality from stroke resulting from Afib, and are less likely to receive treatment for Afib. University of Maryland Department of Neurology and Vascular Neurology are recruiting women older than 70 years of age to participate in the study.
Read the detailed description
Atrial fibrillation or irregular heart beat is seen in 1/3rd of patients that present with stroke. Atrial fibrillation is being increasingly seen in women older than 70 as women are likely to live longer. Women are more likely to die from atrial fibrillation related stroke and are more likely to have symptoms from uncontrolled atrial fibrillation. They are also less likely to be treated with blood thinners to prevent stroke. This section of the population has been underrepresented in other studies on atrial fibrillation and the aim of this study is to proactively screen women older than 70 who are at risk for atrial fibrillation by using a wearable cardiac monitor.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- Wearable cardiac monitor -Zio patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable cardiac monitor -Zio patchDevice
Women older than 70 years old will be asked to wear a cutaneous cardiac monitor for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Other | Women older than 70 who would wear the Zio patch for 2 weeks Receives: Device: Wearable cardiac monitor -Zio patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of detection of atrial fibrillation
Percentage of women older than 70 found to have atrial fibrillation one year from enrollment
Measured: 1 year
Anticoagulant use for prevention of stroke
Rate of anticoagulant prescription
Measured: 2 years
Secondary outcomes (1)
Device adherence
Rate of compliance with device - participants would be asked if they wore the device as advised for the two weeks and adherence would be reported as a percentage.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start15 Jul 2023
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prachi Mehndiratta, University of Maryland, Baltimore
- Investigators
- Prachi Mehndiratta, MBBS, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444335
- Sponsor's protocol ID
- HP-00099005
- Acronym
- SAFE-W
- Status last verified
- Jan 2026
- First submitted
- 22 Jun 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Andrade JG, Deyell MW, Lee AYK, Macle L. Sex Differences in Atrial Fibrillation. Can J Cardiol. 2018 Apr;34(4):429-436. doi: 10.1016/j.cjca.2017.11.022. Epub 2017 Dec 6.
PubMed 29455950Madsen TE, Howard VJ, Jimenez M, Rexrode KM, Acelajado MC, Kleindorfer D, Chaturvedi S. Impact of Conventional Stroke Risk Factors on Stroke in Women: An Update. Stroke. 2018 Mar;49(3):536-542. doi: 10.1161/STROKEAHA.117.018418. Epub 2018 Feb 8. No abstract available.
PubMed 29438086Gladstone 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years
- ClinicalTrials.gov ID
- NCT05444335
- Acronym / sponsor ID
- SAFE-W / HP-00099005
- Conditions
- Atrial Fibrillation New Onset
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 5 Jul 2022 (actual)
- 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.
Screening for Atrial Fibrillation in Elderly Women (SAFE-W) is a pilot study evaluating the prevalence of atrial fibrillation (Afib) in a rapidly aging segment of the population. Studies have shown that women with Afib are more likely to be symptomatic, have increased mortality from stroke resulting from Afib, and are less likely to receive treatment for Afib. University of Maryland Department of Neurology and Vascular Neurology are recruiting women older than 70 years of age to participate in the study.
Detailed description
Atrial fibrillation or irregular heart beat is seen in 1/3rd of patients that present with stroke. Atrial fibrillation is being increasingly seen in women older than 70 as women are likely to live longer. Women are more likely to die from atrial fibrillation related stroke and are more likely to have symptoms from uncontrolled atrial fibrillation. They are also less likely to be treated with blood thinners to prevent stroke. This section of the population has been underrepresented in other studies on atrial fibrillation and the aim of this study is to proactively screen women older than 70 who are at risk for atrial fibrillation by using a wearable cardiac monitor.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Device: Wearable cardiac monitor -Zio patchWomen older than 70 who would wear the Zio patch for 2 weeks |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Female sex
- No previous diagnosis of atrial fibrillation
- Age ≥70 years
- CHA2DS2-VASc score ≥4
Key exclusion criteria (4 listed)
- Life expectancy < 2 years
- Dementia or other neurologic condition which would make outpatient follow-up difficult
- CHA2DS2-VASc score ≤3
- Any compliance issues - such as heavy alcohol/drug use that would impede follow up.
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 |
|---|---|---|
| Wearable cardiac monitor -Zio patchWomen older than 70 years old will be asked to wear a cutaneous cardiac monitor for 2 weeks. | Device | Intervention arm |
Primary outcome
Rate of detection of atrial fibrillation
Time frame: 1 year
Percentage of women older than 70 found to have atrial fibrillation one year from enrollment
Anticoagulant use for prevention of stroke
Time frame: 2 years
Rate of anticoagulant prescription
1 secondary outcome
Device adherence
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 29455950Andrade JG, Deyell MW, Lee AYK, Macle L. Sex Differences in Atrial Fibrillation. Can J Cardiol. 2018 Apr;34(4):429-436. doi: 10.1016/j.cjca.2017.11.022. Epub 2017 Dec 6.
- Background: PubMed 29438086Madsen TE, Howard VJ, Jimenez M, Rexrode KM, Acelajado MC, Kleindorfer D, Chaturvedi S. Impact of Conventional Stroke Risk Factors on Stroke in Women: An Update. Stroke. 2018 Mar;49(3):536-542. doi: 10.1161/STROKEAHA.117.018418. Epub 2018 Feb 8. No abstract available.
- Background: 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.
- Individual participant dataSharing planned: No
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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.
Prachi Mehndiratta, MBBS principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable cardiac monitor -Zio patch in people with Atrial Fibrillation New Onset, run by University of Maryland, Baltimore at 1 site in United States.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 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 United States. 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?
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?
Rate of detection of atrial fibrillation (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT05444335, which also lists 3 linked publications.
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 23 Jan 2026.