Wearable Cardiac Monitor for Atrial Fibrillation

(SAFE-W Trial)

Overseen By Seemant Chaturvedi, MD

Age: 65+

Sex: Female

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Life expectancy < 2 years, dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wearable monitor for detecting atrial fibrillation (Afib), a heart condition that can lead to stroke, particularly in women over 70. The study aims to determine how common Afib is in older women, who often experience symptoms and face a higher stroke risk but receive less treatment. Participants will wear a Zio patch, a type of wearable cardiac monitor, for two weeks to help detect Afib. Women aged 70 or older, without an Afib diagnosis, and with factors like heart-related issues or high blood pressure, may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance heart health monitoring for older women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Zio patch is safe for screening atrial fibrillation in elderly women?

Research has shown that the Zio patch reliably and safely monitors heart rhythms. Past studies indicate that users generally find it easy to use. Worn on the skin, the patch can track heart activity continuously for up to 14 days. This extended monitoring period helps detect irregular heartbeats more accurately than shorter methods like the 24-hour Holter monitor.

The Zio patch has successfully identified more cases of atrial fibrillation (Afib) compared to some other devices, with no strong evidence of harmful side effects. Most people find it comfortable to wear, and negative reactions are rare. This makes the Zio patch a safe choice for those needing to monitor potential heart issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the wearable cardiac monitor, specifically the Zio patch, because it offers a new way to screen for atrial fibrillation in a convenient, non-invasive manner. Unlike traditional methods that require frequent visits to a clinic for monitoring, this wearable device allows women over 70 to track their heart rhythm continuously for two weeks in the comfort of their own homes. This extended monitoring period increases the chances of detecting irregular heartbeats compared to shorter, intermittent checks. By potentially identifying atrial fibrillation earlier, this method could lead to timely interventions and better management of the condition.

What evidence suggests that the Zio patch is effective for screening atrial fibrillation?

Research shows that the Zio patch, which participants in this trial will wear, effectively detects atrial fibrillation (Afib), a type of irregular heartbeat. Studies have found that the Zio patch can continuously monitor the heart for up to 14 days, making it more effective at identifying heart rhythm problems than traditional monitors. In one study, the Zio patch diagnosed more new cases of Afib than standard methods. Another study showed that people wore the Zio patch longer, which helped catch more irregular heartbeats. Overall, the Zio patch is a promising tool for detecting Afib. ^{2 3 6 7 8}

Who Is on the Research Team?

Prachi Mehndiratta, MBBS

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am female.

I have never been diagnosed with atrial fibrillation.

I am 70 years old or older.

Exclusion Criteria

Any compliance issues - such as heavy alcohol/drug use that would impede follow up

I do not have dementia or other conditions that make outpatient visits hard.

Your CHA2DS2-VASc score is less than or equal to 3.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants wear the Zio patch for 2 weeks to monitor for atrial fibrillation

2 weeks

Follow-up

Participants are monitored for atrial fibrillation detection and device adherence

1 year

Long-term follow-up

Participants are monitored for anticoagulant use for stroke prevention

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Screening for Atrial Fibrillation
• Zio patch

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

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

Screening for Atrial Fibrillation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Atrial Fibrillation Screening for:

• Stroke prevention in high-risk individuals

Approved in United States as AF Screening for:

• Stroke prevention in asymptomatic individuals at high risk

Approved in Canada as Screening for AF for:

• Stroke prevention in elderly individuals

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

A survey of 588 healthcare professionals revealed that 57% currently recommend wearables and apps for detecting atrial fibrillation (AF), with higher endorsement from electrophysiologists and nurses compared to cardiologists.

Despite the interest in using consumer devices for AF screening, nearly 70% of healthcare professionals believe we are not ready for widespread consumer-initiated screening due to concerns about patient anxiety, false positives/negatives, and the need for clear management pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer-led screening for atrial fibrillation using consumer-facing wearables, devices and apps: A survey of health care professionals by AF-SCREEN international collaboration. Boriani, G., Schnabel, RB., Healey, JS., et al.[2021]

A digital atrial fibrillation (AF) screening program using a smartphone app was feasible for elderly participants, with 79% of the 204 registered individuals meeting the target of two sufficient recordings per day.

The program successfully identified potential AF cases, with 3 confirmed diagnoses out of 12 suspected cases, although only 5 out of 12 participants followed through to see a cardiologist, indicating challenges in participant follow-up despite the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of digital atrial fibrillation screening in an elderly population : The Ulm heart rhythm weeks. Birkemeyer, R., Maisch, L., Dahme, T., et al.[2022]

About 3% of patients over 65 years old with hypertension and no known atrial fibrillation (AF) may have more than 6 minutes of undetected AF when monitored with a continuous 14-day ECG, indicating a significant prevalence of previously undiagnosed AF.

Patients with more than 6 minutes of AF have a higher risk of stroke, with an annual rate of 2.18% compared to 0.70% for those with less than 6 minutes of AF, suggesting that identifying AF could be crucial for stroke prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimated incidence of previously undetected atrial fibrillation on a 14-day continuous electrocardiographic monitor and associated risk of stroke. McIntyre, WF., Wang, J., Benz, AP., et al.[2022]

In a study involving 2659 participants, immediate use of a self-applied wearable ECG patch led to a significantly higher detection rate of atrial fibrillation (AF) after 4 months (3.9% vs. 0.9% in delayed monitoring), highlighting its efficacy in early identification of AF.

Active monitoring not only increased the diagnosis of AF but also resulted in a higher initiation of anticoagulant therapy and more outpatient visits, indicating that while it improves detection and treatment, it also raises healthcare resource utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. Steinhubl, SR., Waalen, J., Edwards, AM., et al.[2022]

Wearable technology, particularly smartwatches using photoplethysmography (PPG), shows promise in effectively screening for asymptomatic atrial fibrillation (AF), which is crucial since AF can lead to strokes in individuals who may not even know they have it.

While smartwatches can increase the detection of AF cases compared to traditional methods, they should be viewed as a preliminary screening tool rather than a definitive diagnostic method, necessitating follow-up with healthcare professionals for confirmation and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apple Watch, Wearables, and Heart Rhythm: where do we stand? Raja, JM., Elsakr, C., Roman, S., et al.[2020]

The CANDLE-AF study is a multicenter, randomized controlled trial involving 600 patients with transient ischemic attack or ischemic stroke, aiming to evaluate the effectiveness of a 72-hour single-patch monitor for detecting atrial fibrillation (AF) compared to standard monitoring strategies.

The study will assess whether the more convenient single-patch monitor can improve AF detection rates and potentially influence treatment decisions, such as switching from antiplatelet to anticoagulant therapy, which could impact patient outcomes within one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implications of Atrial Fibrillation Detection Using Wearable Devices in Patients With Cryptogenic Stroke (CANDLE-AF) Trial: Design and Rationale. Jung, S., Lee, HA., Kang, IS., et al.[2023]

The developed smartwatch algorithm for detecting Atrial Fibrillation (AF) demonstrated high sensitivity (87.8%) and specificity (97.4%) in a real-world population, indicating its effectiveness for continuous monitoring of this cardiac condition.

The algorithm not only functions well during daily activities but also accurately estimates AF burden, achieving a 98% correlation with ground truth measurements, which highlights its potential for practical use in managing AF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrial Fibrillation Detection and Atrial Fibrillation Burden Estimation via Wearables. Zhu, L., Nathan, V., Kuang, J., et al.[2022]

The Amazfit Health Band 1S, which combines photoplethysmographic (PPG) and electrocardiogram (ECG) technologies with an AI algorithm, demonstrated high sensitivity (88.00%) and specificity (96.41%) for detecting atrial fibrillation (AF) in a study of 401 patients.

When ECG readings from the wristband were evaluated by physicians, the sensitivity and specificity improved significantly, reaching 96.67% and 98.01%, respectively, indicating that this device could be a reliable tool for AF detection in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new smart wristband equipped with an artificial intelligence algorithm to detect atrial fibrillation. Chen, E., Jiang, J., Su, R., et al.[2021]

The SAFER trial is a large-scale study involving over 100,000 participants aged 70 and older, aimed at determining if screening for atrial fibrillation (AF) can effectively reduce the risk of stroke over an average follow-up of 5 years.

The pilot study, which includes approximately 12,600 participants from 36 UK general practices, will assess the feasibility of AF detection and the uptake of anticoagulation therapy, providing crucial data to inform the main trial's design and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster randomised controlled trial of screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the pilot study for the SAFER trial. Williams, K., Modi, RN., Dymond, A., et al.[2023]

Screening for atrial fibrillation (AF) can help identify asymptomatic cases earlier, potentially leading to better treatment outcomes, but most existing evidence focuses on symptomatic AF.

Using new screening devices like photoplethysmography and single-lead electrocardiography can enhance the effectiveness and cost-effectiveness of AF detection, especially when screening is done more frequently in higher-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrial Fibrillation Population Screening. Gruwez, H., Proesmans, T., Evens, S., et al.[2021]

In a study of 7107 elderly individuals (average age 74), screening for atrial fibrillation (AF) revealed a prevalence of 6.1%, with 3.6% being newly diagnosed, highlighting the importance of opportunistic screening in this age group.

Participants with screen-detected AF had a significantly higher risk of mortality (2.3% vs. 0.8%) and hospitalization for cardiovascular causes (10.6% vs. 5.5%) within one year, indicating that early detection of AF can help identify individuals at greater health risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screen-detected atrial fibrillation predicts mortality in elderly subjects. Zink, MD., Mischke, KG., Keszei, AP., et al.[2021]

Citations

1. irhythmtech.com irhythmtech.com/us/en/who-we-are/news-events/zio-by-irhythm-shows-significantly-higher-documentation-of-atrial-fibrillation-and-atrial-flutter-compared-to-holter-monitors-event-monitors

Zio® by iRhythm Shows Significantly Higher ... Zio XT was associated with significantly higher documentation 1 of AF/AFL -related supraventricular tachycardias and non-sustained ventricular tachycardia.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31045463/

Cardiac arrhythmia detection outcomes among patients ... Findings from the review suggest that long-term, continuous, uninterrupted monitoring with Zio results in longer patient wear times and higher cardiac ...

3. irhythm2024rd.q4web.com irhythm2024rd.q4web.com/news/news-details/2025/iRhythm-Unveils-New-Real-World-Data-at-ACC-25-Demonstrating-the-Benefits-of--Zio-Long-Term-Continuous-Monitoring-for-Arrhythmia-Detection/default.aspx

iRhythm Unveils New Real-World Data at ACC.25 ... Zio LTCM provides uninterrupted, continuous monitoring for up to 14 days, enabling more accurate and timely detection of actionable arrhythmias.

4. investors.irhythmtech.com investors.irhythmtech.com/news/news-details/2024/iRhythm-Technologies-Announces-Results-of-GUARD-AF-Trial/default.aspx

iRhythm Technologies Announces Results of GUARD-AF ... Screening with iRhythm's Zio® XT1 LTCM led to increase in new diagnosis of AF (5.0% vs 3.3%) over an average follow-up of 15 months. No ...

5. medicaldevice-developments.com medicaldevice-developments.com/news/irhythm-announces-results-from-guard-af-study/

iRhythm announces results from GUARD-AF study of its Zio ... The GUARD-AF study showed that screening with Zio XT LTCM led to an increase in the diagnosis of AF compared to usual care. It is the ...

6. irhythmtech.com irhythmtech.com/us/en

Heart Monitor Patch & Device for Arrhythmia Detection | Zio ... 99% of physicians agree with the comprehensive end-of-wear report. Based on a review of all online Zio XT, Zio monitor, and Zio AT end-of-wear reports. Data on ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3882198/

Comparison of 24-hour Holter Monitoring with 14-day ... Extended iRhythm Zio patch monitoring detected more arrhythmia events than 24-hour Holter monitoring in those referred for ambulatory electrocardiographic ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002914921011450

Diagnostic Yield, Outcomes, and Resource Utilization With ... Prolonged monitoring with 14-day Zio XT patch or 30-day event monitor was superior to 24-hour Holter in detecting new AF/AFL but not different ...