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Wearable Cardiac Monitor for Atrial Fibrillation (SAFE-W Trial)

N/A
Recruiting
Led By Prachi Mehndiratta, MBBS
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female sex
No previous diagnosis of atrial fibrillation
Must not have
Dementia or other neurologic condition which would make outpatient follow-up difficult
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is looking at how common atrial fibrillation is in elderly women, as well as how this condition affects symptoms and mortality rates.

Who is the study for?
This trial is for women over the age of 70 who have never been diagnosed with atrial fibrillation but are at higher risk due to their CHA2DS2-VASc score being 4 or more. It's not suitable for those with a life expectancy under two years, dementia, other serious neurological conditions, or substance abuse issues.Check my eligibility
What is being tested?
The SAFE-W pilot study is testing how common atrial fibrillation (Afib) is in older women by using a wearable cardiac monitor called Zio patch. The goal is to better understand Afib prevalence and potentially improve treatment and outcomes.See study design
What are the potential side effects?
Wearing the Zio patch typically has minimal side effects which may include skin irritation or discomfort where the patch adheres to the chest.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
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I have never been diagnosed with atrial fibrillation.
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I am 70 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have dementia or other conditions that make outpatient visits hard.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anticoagulant use for prevention of stroke
Rate of detection of atrial fibrillation
Secondary outcome measures
Device adherence

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 Intervention
Women older than 70 who would wear the Zio patch for 2 weeks

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
695 Previous Clinical Trials
376,911 Total Patients Enrolled
Prachi Mehndiratta, MBBSPrincipal InvestigatorUniversity of Maryland, Baltimore

Media Library

Screening for Atrial Fibrillation Clinical Trial Eligibility Overview. Trial Name: NCT05444335 — N/A
Atrial Fibrillation Research Study Groups: Intervention arm
Atrial Fibrillation Clinical Trial 2023: Screening for Atrial Fibrillation Highlights & Side Effects. Trial Name: NCT05444335 — N/A
Screening for Atrial Fibrillation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05444335 — N/A
~28 spots leftby Dec 2024
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