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

Starting soon · Not applicable

Conditions studied: Atrial Fibrillation

In brief

* 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 facts

Study ID

NCT06953778

Run by

VA Office of Research and Development

People needed

24060

Starts

2027-03-08

Expected to finish

2033-10-03

Last updated by the study team

2026-06-30

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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