Skip to content

Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05444335
Acronym
SAFE-W
Enrollment
120
Registered
2022-07-05
Start date
2023-07-15
Completion date
2026-12-15
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation New Onset

Brief 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.

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.

Interventions

DEVICEWearable cardiac monitor -Zio patch

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

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
70 Years to 100 Years
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

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of detection of atrial fibrillation1 yearPercentage of women older than 70 found to have atrial fibrillation one year from enrollment
Anticoagulant use for prevention of stroke2 yearsRate of anticoagulant prescription

Secondary

MeasureTime frameDescription
Device adherence1 yearRate 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPrachi Mehndiratta, MBBS

University of Maryland, Baltimore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026