Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation New Onset
• Interventions: Device: Wearable cardiac monitor -Zio patch

• Registration Number: NCT05444335
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-05
• Study Start: 2023-07-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-12-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Wearable cardiac monitor -Zio patch	Women older than 70 who would wear the Zio patch for 2 weeks

Primary Outcome Measures

Name	Time	Method
Anticoagulant use for prevention of stroke	2 years	Rate of anticoagulant prescription
Rate of detection of atrial fibrillation	1 year	Percentage of women older than 70 found to have atrial fibrillation one year from enrollment

Secondary Outcome Measures

Name	Time	Method
Device adherence	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.

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States