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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorVA Office of Research and Development

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

24,060 Participants
are divided into 2 treatment groups
Group A: Systematic Screening ArmExperimental treatment 1 intervention
Group B: No Screening ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
3 years, assessed remotely via electronic administrative records
2

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).

Time frame
3 years, assessed remotely via electronic administrative records
3

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).

Time frame
3 years, assessed remotely via electronic administrative records
4

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).

Time frame
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.

Time frame
3 years

Other outcomes

Sponsors and contacts

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