The Effectiveness of Patch-Based Screening for Pre-Symptomatic Atrial Fibrillation to Improve Patient Outcome

NCT06953778 | Not Yet Recruiting FDA Device

• 2 other identifiers: 2037S2037
• Study Type: interventional
• Target: 24,060
• Locations: 1 country
• Sites: 1

Brief 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.
• 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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Ischemic Stroke

Outcome Measures

Primary Outcomes (6)

• 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).

  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).

  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).

  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).

  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).

  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).

  3 years, assessed remotely via electronic administrative records

Secondary Outcomes (1)

• Rate of New Diagnosis of AF

  3 years

Study Arms (2)

Systematic Screening Arm

EXPERIMENTAL

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

Device: Zio XT® Patch

No Screening Arm

NO INTERVENTION

Participants randomized to this arm will receive usual care.

Interventions

Zio XT® Patch DEVICE

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.

Also known as: Zio Patch

Systematic Screening Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Paul A. Heidenreich, MD MS

  VA Palo Alto Health Care System, Palo Alto, CA

  STUDY CHAIR

Central Study Contacts

Mustabeen Ashfaq, MS

CONTACT

(857) 364-6026; mustabeen.ashfaq@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is unblinded. Randomization will occur via an online tool developed for the study. Each participating site will have a separate block randomization scheme with random block size, programmed into the randomization tool before the start of the study.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 1, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2032
• Study Completion (Estimated): October 3, 2033
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)