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

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
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

SAFE-W Trial 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.

SAFE-W Trial Eligibility Criteria

Inclusion Criteria

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

SAFE-W Trial 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

SAFE-W 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
687 Previous Clinical Trials
374,526 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this test still open to participants?

"According to records present on clinicaltrials.gov, this clinical trial is not actively welcoming participants at this time. The study was published on June 15th 2022 and its latest update occurred two weeks later. While the trial isn't searching for applicants right now, there are 477 other trials that currently require volunteers."

Answered by AI

Could I be a potential participant in this experiment?

"To partake in this research study, applicants must be aged between 70 and 100 years old and have a newly developed case of atrial fibrillation. This trial requires 120 participants in total."

Answered by AI

Is the enrollment for this investigation restricted to individuals aged 30 or above?

"Patients must be aged between 70 and 100 to meet the eligibility requirements for this research project. Additionally, there are 11 studies available for minors, while 474 trials exist that cater to those over 65 years old."

Answered by AI
~56 spots leftby Dec 2024