Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

NCT05444335 | Active Not Recruiting DMC FDA Device

• 1 other identifier: HP-00099005
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation New Onset

Outcome Measures

Primary Outcomes (2)

• Rate of detection of atrial fibrillation

  Percentage of women older than 70 found to have atrial fibrillation one year from enrollment

  1 year

• Anticoagulant use for prevention of stroke

  Rate of anticoagulant prescription

  2 years

Secondary Outcomes (1)

• Device adherence

  1 year

Study Arms (1)

Intervention arm

OTHER

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

Device: Wearable cardiac monitor -Zio patch

Interventions

Wearable cardiac monitor -Zio patch DEVICE

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

Intervention arm

Eligibility Criteria

• Age: 70 Years - 100 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (3)

• Andrade JG, Deyell MW, Lee AYK, Macle L. Sex Differences in Atrial Fibrillation. Can J Cardiol. 2018 Apr;34(4):429-436. doi: 10.1016/j.cjca.2017.11.022. Epub 2017 Dec 6.

  PMID: 29455950 BACKGROUND

• Madsen TE, Howard VJ, Jimenez M, Rexrode KM, Acelajado MC, Kleindorfer D, Chaturvedi S. Impact of Conventional Stroke Risk Factors on Stroke in Women: An Update. Stroke. 2018 Mar;49(3):536-542. doi: 10.1161/STROKEAHA.117.018418. Epub 2018 Feb 8. No abstract available.

  PMID: 29438086 BACKGROUND

• Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038.

  PMID: 33625468 BACKGROUND

Study Officials

• Prachi Mehndiratta, MBBS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 5, 2022
• Study Start: July 15, 2023
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)