Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT01970969
Eligibility Criteria:
Inclusion Criteria:
* Symptoms of high clinical suspicion for atrial fibrillation prompting referral for ambulatory cardiac rhythm monitoring for potential atrial fibrillation.
AND
* At high risk for atrial fibrillation, defined as any one of the following: ischemic stroke with no defined etiology (In prior 6 months) \[3, 4, 6, 7\], hypertension \[33\], increased body mass index (BMI \>30kg/m2) \[33\], heart failure \[33\], clinically significant murmur \[33\], prolonged PR interval on resting ECG \[33\], chronic kidney disease \[34\], hypertrophic cardiomyopathy \[35\], congenital heart disease \[36\], chronic obstructive pulmonary disease \[37, 38\], sleep apnea \[39-41\], thyroid disease \[42, 43\], family history of atrial fibrillation \[44\], diabetes \[45\] or excess alcohol consumption (Male \> 14 drinks/week, Female \>7 drinks/week)\[46\].
* Age 40 years or older
* Capable of providing informed consent
* Capable of wearing a Zio Patch for up to 14 days
* Capable of providing a blood sample
Exclusion Criteria:
* Previously documented atrial fibrillation or atrial flutter.
* Prior cardiac surgery (coronary artery bypass grafting, valve replacement or repair, pericardial stripping, etc) within the past 30 days.
* Hyperthyroidism.
* Have known skin allergies, conditions, or sensitivities (e.g. allergy to adhesives, psoriasis) as the Zio Patch should not be used on patients with known skin allergies, conditions, or sensitivities.
* Are receiving pacing therapy.
* Are anticipated to receive or require external cardiac defibrillation during the monitoring period.
* Are anticipated to have exposure to high frequency surgical equipment during the monitoring period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01970969
Study Brief:
Protocol Section:
NCT01970969