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Active, Not Recruiting

NCT Number: NCT05444335

Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation New Onset

Age range

70 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female sex
  • No previous diagnosis of atrial fibrillation
  • Age ≥70 years
  • CHA2DS2-VASc score ≥4

Exclusion criteria

  • 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.

Treatment and study plan

Wearable cardiac monitor -Zio patch

Device

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

Primary outcomes

  1. 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

  2. Anticoagulant use for prevention of stroke

    Time frame: 2 years

    Rate of anticoagulant prescription

Secondary outcomes

  1. Device adherence

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Acronym: SAFE-W

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2022
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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