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 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT04209959
Eligibility Criteria:
Inclusion Criteria:
* Documented symptomatic persistent or longstanding persistent AF
* An absence of response to, unacceptable side effects from, or unwillingness to take antiarrhythmic agents
* Willingness to receive combined ablation strategy, including bilateral circumferential pulmonary vein isolation and linear ablation
* Failure to terminate AF to after combined ablation strategy
* Willingness to receive intravenous treatment with nifekalant during the procedure
Exclusion Criteria:
* A history of nontraumatic intracerebral hemorrhage at any time
* Gastrointestinal bleeding within the past six months
* Major surgery within thirty days
* A known bleeding diathesis or coagulation disorder
* A confirmed thrombus in the left atrium by esophageal ultrasound
* Renal failure requiring dialysis
* Pregnant or lactating
* A left ventricular ejection fraction (LVEF) of 30% or less
* Ventricular tachycardia with prolonged QT interval
* Patients with QTc interval of more than 500 ms
* Torsades de pointes (Tdp), or Brugada syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04209959
Study Brief:
Protocol Section:
NCT04209959