← Back to Search

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

Timeline

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

Select...

I am female.

Select...

I have never been diagnosed with atrial fibrillation.

Select...

I am 70 years old or older.

SAFE-W Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,536 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

Recent research and studies

Canadian Journal of CardiologyJournal

Sex Differences in Atrial Fibrillation

Andrade, Jason G., Marc W. Deyell, Andrea Y.K. Lee, and Laurent Macle. 2018. “Sex Differences in Atrial Fibrillation”. Canadian Journal of Cardiology. Elsevier BV. doi:10.1016/j.cjca.2017.11.022.

StrokeJournal

Impact of Conventional Stroke Risk Factors on Stroke in Women

Madsen, Tracy E., Virginia J. Howard, Monik Jiménez, Kathryn M. Rexrode, Maria Czarina Acelajado, Dawn Kleindorfer, and Seemant Chaturvedi. 2018. “Impact of Conventional Stroke Risk Factors on Stroke in Women”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/strokeaha.117.018418.

JAMA CardiologyJournal

Screening for Atrial Fibrillation in the Older Population

Gladstone, David J., Rolf Wachter, Katharina Schmalstieg-Bahr, F. Russell Quinn, Eva Hummers, Noah Ivers, Tamara Marsden, et al.. 2021. “Screening for Atrial Fibrillation in the Older Population”. JAMA Cardiology. American Medical Association (AMA). doi:10.1001/jamacardio.2021.0038.

clinicaltrials.govStudy