CClinicalTrials.gg
Active, not recruitingNCT05444335SAFE-WUpdated Jan 23, 2026

Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

An interventional study of Wearable cardiac monitor -Zio patch in Atrial Fibrillation New Onset, sponsored by University of Maryland, Baltimore. Active, not recruiting at 1 site in United States. Open to female participants aged 70 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
70 Years to 100 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Atrial Fibrillation New Onset
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In context

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Female sex
  2. No previous diagnosis of atrial fibrillation
  3. Age ≥70 years
  4. CHA2DS2-VASc score ≥4

Exclusion criteria

Exclusion Criteria:

  1. Life expectancy \< 2 years
  2. Dementia or other neurologic condition which would make outpatient follow-up difficult
  3. CHA2DS2-VASc score ≤3
  4. Any compliance issues - such as heavy alcohol/drug use that would impede follow up.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Other
    Intervention arm

    Women older than 70 who would wear the Zio patch for 2 weeks

    Device: Wearable cardiac monitor -Zio patch

Interventions

  • DeviceWearable cardiac monitor -Zio patch

    Women older than 70 years old will be asked to wear a cutaneous cardiac monitor for 2 weeks.

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What researchers measure

Primary outcomes

  1. Rate of detection of atrial fibrillation

    Percentage of women older than 70 found to have atrial fibrillation one year from enrollment

    Time frame: 1 year

  2. Anticoagulant use for prevention of stroke

    Rate of anticoagulant prescription

    Time frame: 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.

    Time frame: 1 year

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Study locations

1 site
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
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References and documents

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 29455950 ↗
  • Madsen 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 29438086 ↗
  • 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05444335
Lead sponsor
University of Maryland, Baltimore
Responsible party
Prachi Mehndiratta (Assistant Professor, University of Maryland, Baltimore) — Principal investigator
First posted
Jul 5, 2022
Start date
Jul 15, 2023
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Jan 23, 2026

Study contacts

Prachi Mehndiratta, MBBS
principal investigator · University of Maryland, Baltimore

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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