Atrial FibrillationVALIANT-AF-SNCT06953778
The Effectiveness of Patch-Based Screening for Pre-Symptomatic Atrial Fibrillation to Improve Patient Outcome
A study testing Zio XT® Patch in people with Atrial Fibrillation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The goal of the screening trial is to determine whether early screening for atrial fibrillation improves outcomes, including lowering the chance of death, hospitalization for stroke, blood clots, heart failure, heart attack, and severe bleeding reduces the risk of stroke or heart failure. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Zio XT® Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24,060 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2027to 3 Oct 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, age >=65 years
- CHA2DS2-Vasc score >=3. The score is comprised of age (2 points for 75, 1 point for 65-74), sex (1 point for female), history of stroke, TIA, or systemic embolism (2 points), and history of heart failure, hypertension, vascular disease (including MI, peripheral artery disease, or aortic plaque), or diabetes (1 point each).
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current use of anticoagulation
- Diagnosis of AF (from administrative records or per patient during consent)
- Cardio-thoracic surgery in the prior 3 months
- Presence of pacemaker, implantable defibrillator, or implanted cardiac monitor
- Clinically significant allergy to adhesives, as reported by the patient during screening for trial enrollment
- Planned use of a brain or spinal-cord stimulator, TENS unit, or MRI scan during the period when the Zio Patch will be worn
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Mustabeen Ashfaq, MS, 857-364-6026, mustabeen.ashfaq@va.gov
Paul A. Heidenreich, MD MS
About this study
Official title: CSP #2037S - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-S) Trial
- The goal of the screening trial is to determine whether early screening for atrial fibrillation improves outcomes, including lowering the chance of death, hospitalization for stroke, blood clots, heart failure, heart attack, and severe bleeding reduces the risk of stroke or heart failure.
- Atrial fibrillation is a common heart condition in which one of the heart chambers doesn't follow a normal rhythm. Blood clots can form as a result, and they can travel to the brain and cause strokes, or to other organs.
- Almost everyone with atrial fibrillation is treated with drugs called anticoagulants ("blood thinners") to reduce the risk of stroke. These drugs also increase the risk of bleeding.
- Testing for atrial fibrillation is usually done for patients who have symptoms of an irregular or unusually fast or slow heartbeat, often called "palpitations" or a sensation of the heart pounding or stopping for a short period of time.
- What is not known is whether screening people who do not have symptoms of atrial fibrillation, but who are at above-average risk of getting atrial fibrillation, will reduce death, hospitalization for stroke, blood clots, heart failure more than it increases hospitalization for severe bleeding.
- People who participate in the trial who are selected by chance to receive screening will wear a small heart-rate monitor (Zio Patch) on their skin for 14 days and then return it to the manufacturer. Their doctors will be notified about the results and will make decisions about any treatment to recommend.
- The screening trial is expected to enroll about 24,000 VA patients nationwide and to last 7 years, but each person's active participation in the trial is completed after sending in the Zio Patch. After that, the study team will just collect information from the participant's electronic medical records.
Read the detailed description
The study hypothesis is that screening for atrial fibrillation (AF) in participants at risk for AF will be associated with a reduction in adverse cardiovascular outcomes. This trial will enroll 24,060 participants with CHA2DS2-VASc score >=3, aged >=65 years without known AF to be randomized to either receive systematic screening at-home with a Zio Patch monitor or to no screening (usual care). If Zio Patch readings indicate AF or another significant arrhythmia, the provider(s) will be advised to consider a set of evidence-based guidelines, including but not limited to anticoagulation. The primary outcome is time to a composite of several events that are complications of AF or its treatment, all of them assessed remotely via electronic administrative records.
The Primary Objective is to assess the effect of a strategy for screening for pre-symptomatic AF on a composite outcome of complications of AF and its treatment, in a prospective, randomized trial. Secondary Objective is to assess the effectiveness of this strategy on the rate of clinical diagnosis of AF.
Primary Endpoint: composite of 1) hospitalization for stroke; 2) hospitalization for systemic embolism; 3) hospitalization for heart failure; 4) hospitalization for acute coronary syndrome; 5) hospitalization for bleeding; 6) death from any cause.
Secondary Endpoints: diagnosis of AF (ICD-10 codes); individual components of the composite outcome.
24,060 patients age >=65 years at approximately 100 VA Medical Centers throughout the US; representation of every VISN and likely every US state is anticipated. CHA2DS2-VASc score >=3 ensures that participants have cardiovascular risk factors (with age considered such a risk factor) but are not necessarily chronically ill. Those already diagnosed with AF, diagnosed with dementia, or anticoagulated long-term for reasons other than AF will be excluded. The VA population is ~89% male with skewing that increases with age; inclusion of Veterans aged 55-64 years and the fact that female sex contributes 1 point to the CHA2DS2-VASc score should increase enrollment of women. Because of the pragmatic trial design and the fact that AF in Veterans <age 55 years is very uncommon, the study population will be restricted to only those >=55 years with AF. However, the primary outcome analysis will include only those Veterans age 65 years in order to assess outcomes from the EHR and other electronic data sources remotely.
Approximately 100 VA Medical Centers with primary care and outpatient cardiology services will be used. The study will not include sites outside the US.
The trial is planned for 3 years of active enrollment and at least 3 years of remote follow-up of the last enrolled participant, thus 6 years of data collection (3-6 years per patient), with an additional year for the completion of data analysis, 7 years (84 months) total.
Participant duration is less than one month to enroll in the screening trial and complete the Zio Patch screening procedure. After that, clinical management is per the participant's providers, and all data are collected remotely using VA and CMS administrative data.
- Conditions
- Atrial Fibrillation
- Being tested
- Zio XT® Patch
- Keywords
- Atrial Fibrillation, Ischemic Stroke
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zio XT® PatchDevice
Also called Zio Patch
For participants randomized to be systematically screened, ambulatory ECG monitoring of up to 14 days will be performed using the Zio XT® Patch (iRhythm Inc, San Francisco, CA). The Zio XT® patch is a small, cutaneous ambulatory ECG recording device that provides cardiac rhythm monitoring for up to 14 consecutive days (significantly longer than the 48 hours of monitoring provided by a typical Holter Monitor). The device is approved by the Food and Drug Administration and is in routine clinical use, including in the VA system.
| Study group | Role | What they receive |
|---|---|---|
| Systematic Screening Arm | Experimental | Participants randomized to be systematically screened will receive at-home screening with a Zio XT Patch monitor. Receives: Device: Zio XT® Patch |
| No Screening Arm | No intervention | Participants randomized to this arm will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for Stroke
Hospitalization for stroke, as determined by ICD-10 codes associated with hospitalization. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
Measured: 3 years, assessed remotely via electronic administrative records
Hospitalization for Systemic Embolism
Hospitalization for systemic embolism, as determined by ICD-10 codes associated with hospitalization. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
Measured: 3 years, assessed remotely via electronic administrative records
Hospitalization for Heart Failure
Hospitalization for heart failure, as determined by ICD-10 codes associated with hospitalization. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
Measured: 3 years, assessed remotely via electronic administrative records
Hospitalization for Acute Coronary Syndrome
Hospitalization for acute coronary syndrome, as determined by ICD-10 codes associated with hospitalization. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
Measured: 3 years, assessed remotely via electronic administrative records
Hospitalization for Major Bleeding
Hospitalization for major bleeding, as determined by ICD-10 codes associated with hospitalization. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
Measured: 3 years, assessed remotely via electronic administrative records
All-Cause Mortality
Death of any cause, as determined by VA data on vital status. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
Measured: 3 years, assessed remotely via electronic administrative records
Secondary outcomes (1)
Rate of New Diagnosis of AF
Diagnosis of AF will be determined by use of its ICD code or detection of AF sustained for at least 30 seconds using a Zio Patch or other screening device.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start8 Mar 2027 (estimated)
- Primary completion1 Oct 2032 (estimated)
- Study completion3 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For participants randomized to be systematically screened, ambulatory ECG monitoring of up to 14 days will be performed using the Zio XT® Patch. The company (iRhythm, Inc.) provides a detailed summary of findings, followed by review and summary by a trained Certified Cardiographic Technician. A VA cardiologist will review the data (as is standard in clinical use). The report will include, at a minimum: 1) the presence and total duration of any atrial fibrillation; 2) Additional findings relevant to clinical care. Evidence-based guidance for management will be included with the report. Any critical findings are reported immediately to the responsible local physician (site investigator) by iRhythm as is the standard practice.
- Masking
- None (open label)
- Enrolment
- 24,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul A. Heidenreich, MD MS, Study chair, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953778
- Sponsor's protocol ID
- 2037S
- Other IDs
- 2037
- Acronym
- VALIANT-AF-S
- Status last verified
- Jun 2026
- First submitted
- 23 Apr 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #2037S - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-S) Trial
- ClinicalTrials.gov ID
- NCT06953778
- Acronym / sponsor ID
- VALIANT-AF-S / 2037S
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24,060 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 8 Mar 2027 (estimated)
- Primary completion
- 1 Oct 2032 (estimated)
- Study completion
- 3 Oct 2033 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The goal of the screening trial is to determine whether early screening for atrial fibrillation improves outcomes, including lowering the chance of death, hospitalization for stroke, blood clots, heart failure, heart attack, and severe bleeding reduces the risk of stroke or heart failure.
- Atrial fibrillation is a common heart condition in which one of the heart chambers doesn't follow a normal rhythm. Blood clots can form as a result, and they can travel to the brain and cause strokes, or to other organs.
- Almost everyone with atrial fibrillation is treated with drugs called anticoagulants ("blood thinners") to reduce the risk of stroke. These drugs also increase the risk of bleeding.
- Testing for atrial fibrillation is usually done for patients who have symptoms of an irregular or unusually fast or slow heartbeat, often called "palpitations" or a sensation of the heart pounding or stopping for a short period of time.
- What is not known is whether screening people who do not have symptoms of atrial fibrillation, but who are at above-average risk of getting atrial fibrillation, will reduce death, hospitalization for stroke, blood clots, heart failure more than it increases hospitalization for severe bleeding.
- People who participate in the trial who are selected by chance to receive screening will wear a small heart-rate monitor (Zio Patch) on their skin for 14 days and then return it to the manufacturer. Their doctors will be notified about the results and will make decisions about any treatment to recommend.
- The screening trial is expected to enroll about 24,000 VA patients nationwide and to last 7 years, but each person's active participation in the trial is completed after sending in the Zio Patch. After that, the study team will just collect information from the participant's electronic medical records.
Detailed description
The study hypothesis is that screening for atrial fibrillation (AF) in participants at risk for AF will be associated with a reduction in adverse cardiovascular outcomes. This trial will enroll 24,060 participants with CHA2DS2-VASc score >=3, aged >=65 years without known AF to be randomized to either receive systematic screening at-home with a Zio Patch monitor or to no screening (usual care). If Zio Patch readings indicate AF or another significant arrhythmia, the provider(s) will be advised to consider a set of evidence-based guidelines, including but not limited to anticoagulation. The primary outcome is time to a composite of several events that are complications of AF or its treatment, all of them assessed remotely via electronic administrative records.
The Primary Objective is to assess the effect of a strategy for screening for pre-symptomatic AF on a composite outcome of complications of AF and its treatment, in a prospective, randomized trial. Secondary Objective is to assess the effectiveness of this strategy on the rate of clinical diagnosis of AF.
Primary Endpoint: composite of 1) hospitalization for stroke; 2) hospitalization for systemic embolism; 3) hospitalization for heart failure; 4) hospitalization for acute coronary syndrome; 5) hospitalization for bleeding; 6) death from any cause.
Secondary Endpoints: diagnosis of AF (ICD-10 codes); individual components of the composite outcome.
24,060 patients age >=65 years at approximately 100 VA Medical Centers throughout the US; representation of every VISN and likely every US state is anticipated. CHA2DS2-VASc score >=3 ensures that participants have cardiovascular risk factors (with age considered such a risk factor) but are not necessarily chronically ill. Those already diagnosed with AF, diagnosed with dementia, or anticoagulated long-term for reasons other than AF will be excluded. The VA population is ~89% male with skewing that increases with age; inclusion of Veterans aged 55-64 years and the fact that female sex contributes 1 point to the CHA2DS2-VASc score should increase enrollment of women. Because of the pragmatic trial design and the fact that AF in Veterans <age 55 years is very uncommon, the study population will be restricted to only those >=55 years with AF. However, the primary outcome analysis will include only those Veterans age 65 years in order to assess outcomes from the EHR and other electronic data sources remotely.
Approximately 100 VA Medical Centers with primary care and outpatient cardiology services will be used. The study will not include sites outside the US.
The trial is planned for 3 years of active enrollment and at least 3 years of remote follow-up of the last enrolled participant, thus 6 years of data collection (3-6 years per patient), with an additional year for the completion of data analysis, 7 years (84 months) total.
Participant duration is less than one month to enroll in the screening trial and complete the Zio Patch screening procedure. After that, clinical management is per the participant's providers, and all data are collected remotely using VA and CMS administrative data.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For participants randomized to be systematically screened, ambulatory ECG monitoring of up to 14 days will be performed using the Zio XT® Patch. The company (iRhythm, Inc.) provides a detailed summary of findings, followed by review and summary by a trained Certified Cardiographic Technician. A VA cardiologist will review the data (as is standard in clinical use). The report will include, at a minimum: 1) the presence and total duration of any atrial fibrillation; 2) Additional findings relevant to clinical care. Evidence-based guidance for management will be included with the report. Any critical findings are reported immediately to the responsible local physician (site investigator) by iRhythm as is the standard practice.
| Arm | Type | Receives |
|---|---|---|
| Systematic Screening Arm | Experimental | Device: Zio XT® PatchParticipants randomized to be systematically screened will receive at-home screening with a Zio XT Patch monitor. |
| No Screening Arm | No intervention | –Participants randomized to this arm will receive usual care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, age >=65 years
- CHA2DS2-Vasc score >=3. The score is comprised of age (2 points for 75, 1 point for 65-74), sex (1 point for female), history of stroke, TIA, or systemic embolism (2 points), and history of heart failure, hypertension, vascular disease (including MI, peripheral artery disease, or aortic plaque), or diabetes (1 point each).
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current use of anticoagulation
- Diagnosis of AF (from administrative records or per patient during consent)
- Cardio-thoracic surgery in the prior 3 months
- Presence of pacemaker, implantable defibrillator, or implanted cardiac monitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zio XT® PatchAlso: Zio PatchFor participants randomized to be systematically screened, ambulatory ECG monitoring of up to 14 days will be performed using the Zio XT® Patch (iRhythm Inc, San Francisco, CA). The Zio XT® patch is a small, cutaneous ambulatory ECG recording device that provides cardiac rhythm monitoring for up to 14 consecutive days (significantly longer than the 48 hours of monitoring provided by a typical Holter Monitor). The device is approved by the Food and Drug Administration and is in routine clinical use, including in the VA system. | Device | Systematic Screening Arm |
Primary outcome
Hospitalization for Stroke
Time frame: 3 years, assessed remotely via electronic administrative records
Hospitalization for stroke, as determined by ICD-10 codes associated with hospitalization. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
Hospitalization for Systemic Embolism
Time frame: 3 years, assessed remotely via electronic administrative records
Hospitalization for systemic embolism, as determined by ICD-10 codes associated with hospitalization. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
Hospitalization for Heart Failure
Time frame: 3 years, assessed remotely via electronic administrative records
Hospitalization for heart failure, as determined by ICD-10 codes associated with hospitalization. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
Hospitalization for Acute Coronary Syndrome
Time frame: 3 years, assessed remotely via electronic administrative records
Hospitalization for acute coronary syndrome, as determined by ICD-10 codes associated with hospitalization. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
Hospitalization for Major Bleeding
Time frame: 3 years, assessed remotely via electronic administrative records
Hospitalization for major bleeding, as determined by ICD-10 codes associated with hospitalization. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
All-Cause Mortality
Time frame: 3 years, assessed remotely via electronic administrative records
Death of any cause, as determined by VA data on vital status. The primary outcome is time to the first event of stroke, systemic embolism, heart failure, acute coronary syndrome, or major bleeding, or death from any cause (outcomes 1-6).
1 secondary outcome
Rate of New Diagnosis of AF
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul A. Heidenreich, MD MS study chair
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zio XT® Patch in people with Atrial Fibrillation, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustabeen Ashfaq, MS ((857) 364-6026, mustabeen.ashfaq@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization for Stroke (time frame: 3 years, assessed remotely via electronic administrative records). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.