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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT03005366
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≥ 20 and ≤65 year-olds.
2. Patients with paroxysmal AF lasting \<48 hours, in whom pharmacological cardioversion may be indicated.
3. Hemodynamically stable patients (systolic blood pressure \> 100 mm Hg and \< 160 mm Hg. Diastolic blood pressure \<95 mm Hg).
4. Weight of 45-136 kg .
5. Appropriate anticoagulation therapy according to the clinical practice guidelines of the European Society of Cardiology in paroxysmal AF episodes lasting \< 48 hours.
6. Signed informed consent.
Exclusion Criteria:
1. Corrected QT interval\> 440 milliseconds, long QT family or history of 'Torsades de Pointes' syndrome.
2. Symptomatic bradycardia or ventricular rate \<50 bpm without a pacemaker, or QRS interval\> 140 milliseconds.
3. Patients with heart failure regardless of the classification of the New York Heart Association (NYHA).
4. Second or third degree atrioventricular block, or right bundle branch block associated with partial left bundle branch block (bifascicular block).
5. Cardiogenic or septic shock, chronic myocardial infarction, acute coronary syndrome, or heart surgery in the previous 30 days before inclusion.
6. Valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis.
7. Previous unsuccessful electrical cardioversion or longstanding atrial fibrillation (no attempt to convert to sinus rhythm).
8. Treatment with other investigational drug within 60 days before enrollment.
9. Previous treatment with vernakalant.
10. Secondary causes of atrial fibrillation, hyperthyroidism, uncorrected electrolyte imbalance, or digoxin toxicity.
11. IV / oral treatment with Class I or III antiarrhythmics (except amiodarone) in the previous 48 hours.
12. Renal failure with glomerular filtration rate \<35 ml / min.
13. Intravenous / oral amiodarone within the previous 3 months.
14. Pregnant or nursing women.
15. Intolerance or allergy to any of the two drugs being studied.
16. Refusal to sign the informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT03005366
Study Brief:
Protocol Section:
NCT03005366