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

Conditions

• Atrial Fibrillation

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Accepted

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.

Study Details

* 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.

Key Dates

Start date

Jun 1, 2026

Status verified

Apr 2025

Primary completion

Oct 1, 2032

Completion

Oct 3, 2033

Study Design

Enrollment

24,060 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: Systematic Screening Arm
  Participants randomized to be systematically screened will receive at-home screening with a Zio XT Patch monitor.
• No Intervention: No Screening Arm
  Participants randomized to this arm will receive usual care.

Primary Outcome Measure

Hospitalization for Stroke [ Time Frame: 3 years, assessed remotely via electronic administrative records ]

Central Contacts

• Mustabeen Ashfaq, MS
  (857) 364-6026
  [email protected]

Locations (1)

Find similar trials in Palo Alto, CA

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