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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04993456
Eligibility Criteria:
Inclusion Criteria:
* 1\. Clinical diagnosis of no history of atrial fibrillation/flutter;
* 2\. Heart rate ≥50 beats/min;
* 3\. EF \> 40%;
* 4\. No history of emergency cardiac surgery in our hospital;
* 5\. Participate voluntarily and sign the informed consent, and can accept the follow-up of more than 2 years.
Exclusion Criteria:
* 1\. Atrial fibrillation/flutter;
* 2\. Left atrial diameter \>5.5cm;
* 3\. Previous cardiac surgery or emergency surgery (\<12h);
* 4\. Sick sinus node syndrome;
* 5\. Ventricular preexcitation or preexcitation syndrome;
* 6\. Second degree or above atrioventricular block;
* 7.Myocardial infarction occurred within 7 days;
* 8\. Infection, sepsis, rheumatic or inflammatory diseases;
* 9\. Abnormal liver and kidney function (three times higher than the upper limit of normal);
* 10\. Uncontrolled hyperthyroidism, severe obstructive sleep apnea, and acute alcoholism;
* 11\. Any ischemic events (stroke or TIA) that occurred 180 days before the participant signed the informed consent, or any known unresolved complications from previous stroke/TIA;Thrombosis;
* 12\. Patients with other diseases requiring radiotherapy, chemotherapy and long-term hormone therapy;
* 13\. Patients' life expectancy makes it unlikely that follow-up will be completed;
* 14\. Participate in, or are expected to participate in, other clinical trials of any drugs, devices or biologics during the study period;
* 15\. Patients with contraindications to dynamic electrocardiogram;
* 16\. Patients who are unwilling or unable to fully comply with study procedures and follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04993456
Study Brief:
Protocol Section:
NCT04993456