Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years (SAFE-W)

University of Maryland Baltimore (UMB)

Status: Enrolling

Conditions: Atrial Fibrillation New Onset

Treatments: Device: Wearable cardiac monitor -Zio patch

Study type: Interventional

Funder types: Other

Identifiers

NCT05444335

HP-00099005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 70 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Intervention arm

Other group

Description:

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

Treatment:

Device: Wearable cardiac monitor -Zio patch