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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT05456204
Eligibility Criteria:
Inclusion Criteria:
2\. Patients with paroxysmal or persistent forms of AF/AFL and early (less than 90 days) or late (more than 90 days) arrhythmia recurrence after catheter radiofrequency ablation or balloon cryoablation of pulmonary veins.
3\. Indications for SR recovery. 4. Consent of the patient.
Exclusion Criteria:
1. Arrhythmogenic effect of antiarrhythmic drugs III class in history;
2. Chronic kidney disease with a decrease in glomerular filtration rate less than 30 ml / min / 1.73 m2;
3. Chronic heart failure (functional class IV);
4. Acute coronary syndrome;
5. Bronchial asthma of an uncontrolled course and / or severe respiratory failure.
6. The need for the use of drugs that increase the duration of the QT interval drugs without the possibility of withdrawal
7. Atrioventricular blockade of 2-3 degrees (with the exception of patients with an implanted pacemaker);
8. Dysfunction of the sinoatrial node (with the exception of patients with an implanted pacemaker);
9. Bradysystolic atrial fibrillation (heart rate \<50 beats/min);
10. Duration of the QT interval \>440 ms;
11. Hemodynamic instability requiring emergency cardioversion;
12. Contraindications to anticoagulant therapy;
13. Thyrotoxicosis or decompensated hypothyroidism;
14. Uncorrected electrolyte disturbances at the time of cardioversion (potassium level less than 3.5 mmol/l);
15. Pregnancy and breastfeeding period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05456204
Study Brief:
Protocol Section:
NCT05456204