Screening for Atrial Fibrillation with Zio XT® Patch
This study is looking at whether early screening for atrial fibrillation (AFib), a common heart condition where your heart beats irregularly, can improve health outcomes. If you're 65 or older and have a higher risk of stroke (CHA2DS2-Vasc score of 3 or more), you might be eligible. Half of the participants will use a Zio XT® Patch, a small device that monitors your heart rhythm for up to 14 days. The other half will receive usual care without screening. Researchers will then compare how many people in each group are hospitalized for stroke, blood clots, or heart failure over three years. The study aims to see if finding AFib early can reduce these serious health problems.
- Study design
- This is an interventional study planning to enroll 24,060 participants. Participants will be randomly assigned to either receive systematic screening with a Zio XT® Patch or to no screening (usual care).
- What's involved
- If you are in the screening group, you will wear a Zio XT® Patch for up to 14 days. Your health records will be assessed remotely for three years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for three years to track hospitalizations for stroke, systemic embolism, and heart failure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Effectiveness of Patch-Based Screening for Pre-Symptomatic Atrial Fibrillation to Improve Patient Outcome
At a glance
Conditions
NCT06953778
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, Californiastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Paul A. Heidenreich, MD MS · STUDY_CHAIR · VA Palo Alto Health Care System, Palo Alto, CA
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Hospitalization for Stroke3 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 Embolism3 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 Failure3 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 Syndrome3 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 Bleeding3 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 Mortality3 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).