Zio XT® Patch for Atrial Fibrillation

(VALIANT-AF-S Trial)

Overseen By Mustabeen Ashfaq, MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Anticoagulants

Disqualifiers: Atrial fibrillation, Recent surgery, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early screening for atrial fibrillation, a common heart rhythm issue, can improve health outcomes such as reducing strokes or heart failure. Selected participants will wear a Zio XT® Patch, a small heart-rate monitor, for 14 days to detect atrial fibrillation. The trial seeks individuals aged 65 or older with a history of heart problems, high blood pressure, or diabetes. Researchers will compare usual care to this new screening method to assess its effectiveness. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance future heart health screening methods.

Will I have to stop taking my current medications?

If you are currently using anticoagulation (blood thinners), you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that the Zio XT® Patch is safe for atrial fibrillation screening?

Research shows that the Zio XT® Patch is generally easy for people to use. Studies have found that wearing this small device on the skin for up to 14 days helps detect irregular heartbeats, such as atrial fibrillation, without causing major side effects.

One study found that the Zio Patch detected these irregular heartbeats more effectively than standard methods, indicating its effectiveness. Additionally, users reported no major problems or discomfort from wearing the patch.

For those considering joining a trial using the Zio XT® Patch, current evidence suggests it is a safe option with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Zio XT® Patch for atrial fibrillation because it introduces a novel way to monitor heart rhythms right from home. Unlike traditional methods that may require frequent visits to a doctor's office, this patch offers continuous, at-home monitoring, making it more convenient and potentially more comprehensive. The Zio XT® Patch's ability to provide long-term, uninterrupted data could lead to earlier detection and treatment adjustments, which is crucial for managing atrial fibrillation effectively.

What evidence suggests that the Zio XT® Patch is effective for atrial fibrillation screening?

Studies have shown that the Zio XT® Patch effectively detects atrial fibrillation, a heart rhythm problem, over extended periods. It accurately identifies irregular heart rhythms in about 79% of cases. Research indicates that people wearing the Zio Patch tend to keep it on longer, enhancing heart monitoring and detection of irregular heartbeats. In this trial, participants in the Systematic Screening Arm will receive at-home screening with a Zio XT Patch monitor, while those in the No Screening Arm will receive usual care. Another study found that the Zio Patch led to faster detection of atrial fibrillation compared to usual care. This evidence supports the idea that the Zio XT® Patch can effectively monitor heart rhythms and potentially catch issues early. ^{1 4 6 7 8}

Who Is on the Research Team?

Paul A. Heidenreich, MD MS

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

This trial is for individuals at above-average risk of developing atrial fibrillation who don't yet show symptoms. Participants will wear a heart-rate monitor patch for two weeks. Those with existing heart rhythm issues, on anticoagulants, or conditions that could interfere with the study are likely excluded.

Inclusion Criteria

I am 65 years old or older.

My risk score for stroke is 3 or higher.

Exclusion Criteria

I am currently taking blood thinners.

I have been diagnosed with atrial fibrillation.

I have not had heart or chest surgery in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Less than 1 month

1 visit (in-person)

Systematic Screening

Participants randomized to systematic screening will receive at-home screening with a Zio XT Patch monitor for 14 days

2 weeks

At-home procedure

Follow-up

Participants are monitored for safety and effectiveness after screening through remote data collection

3 years

Data Analysis

Completion of data analysis after the follow-up period

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Zio XT® Patch

Trial Overview The Zio XT® Patch, a wearable heart-rate monitor, is being tested to see if early screening can reduce risks associated with atrial fibrillation such as stroke and heart failure without increasing severe bleeding due to treatment.

How Is the Trial Designed?

Group I: Systematic Screening Arm Experimental Treatment 1 Intervention

Participants randomized to be systematically screened will receive at-home screening with a Zio XT Patch monitor.

Group II: No Screening Arm Active Control 1 Intervention

Participants randomized to this arm will receive usual care.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. irhythmtech.com irhythmtech.com/us/en/who-we-are/news-events/results-of-four-studies-of-irhythms-portfolio-presented-at-american-heart-association-22

Results of Four Studies Demonstrating Clinical, Economic ... The study of over ten thousand patients found not only a high diagnostic yield (79%) with Zio AT, but an unexpectedly high burden of ...

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

News Details - iRhythm Technologies, Inc. - Investor Relations Researchers assessed SRC in patients ≥18 years who wore a Zio® monitor or Zio® XT LTCM for >7 to 14 days between June 2023 and July 2024. These ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06953778

Study Details | NCT06953778 | The Effectiveness of Patch ... The Zio XT® patch is a small, cutaneous ambulatory ECG recording device that provides cardiac rhythm monitoring for up to 14 consecutive days ( ...

5. investors.irhythmtech.com investors.irhythmtech.com/news/news-details/2025/AMALFI-Randomized-Clinical-Trial-Results-Demonstrate-Increased-Atrial-Fibrillation-Diagnosis-with-Home-Based-Long-Term-Continuous-ECG-Monitoring-Using-iRhythm-Technologies-ZioLTCM-Service/default.aspx

AMALFI Randomized Clinical Trial Results Demonstrate ... A remote screening strategy with the Zio LTCM service led to an increase in AFib detection and shorter time to diagnosis versus usual care.

6. 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7854334/

Newer Diagnostic and Cost-Effective Ways to Identify ... Compared with the first 48 hours of monitoring, the overall diagnostic yield for Zio Patch was greater for any arrhythmia (62.2% vs 43.9%; p< ...

8. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/amalfi-trial-zio-ecg-monitoring-increases-afib-diagnosis/

AMALFI Trial: Zio ECG Monitoring Increases AFib Diagnosis AMALFI reported a 6.8% new AFib diagnosis rate with a single 14-day Zio long-term continuous monitoring patch, compared to 5.4% on usual care ...