Purpose

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.

Condition

Eligibility

Eligible Ages
Between 70 Years and 100 Years
Eligible Genders
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

  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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Intervention arm
Women older than 70 who would wear the Zio patch for 2 weeks
  • Device: Wearable cardiac monitor -Zio patch
    Women older than 70 years old will be asked to wear a cutaneous cardiac monitor for 2 weeks.

Recruiting Locations

University of Maryland Medical Center
Baltimore, Maryland 21201
Contact:
Prachi Mehndiratta
410-328-5803
pmehndiratta@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Prachi Mehndiratta, MBBS
410-328-4170
pmehndiratta@som.umaryland.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.