← Back to all trials
Not Yet Recruiting
NCT05655468
Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation
Conditions: Atrial Fibrillation
Sex: All
Ages: 18 Years – 80 Years
Phase: PHASE4
Enrollment: 268
Sponsor: Shanghai East Hospital
Summary
Recurrence rate remains high after radiofrequency ablation in patients with non-paroxysmal atrial fibrillation(AF).
Prolonged use of anti-arrhythmic drugs (AAD) beyond the post-ablation blanking has been adopted as a solution but without sufficient clinical evidence.
Dronedarone is an AAD valid to maintain sinus rhythm and has fewer side effect than other AAD for long-term use.We sought to investigate the effect of prolonged use of dronedarone on recurrence of non-paroxysmal AF patients beyond the post-blanking period within the first year after ablation.
Eligibility Criteria
Inclusion Criteria:Aged 18-80 years;Diagnosis of non-paroxysmal AFUndergoing AF ablation for the first timeExclusion Criteria:Unwilling to take or intolerant to dronedarone;Hypersensitivity to the drug ingredientPatients with decompensated heart failure, class NYHA IV, or left ventricular ejection fraction (LVEF) ≤40%Bradycardia <50 bpmQTc Bazett interval ≥500ms or PR interval >280msII or III atrioventricular (AV) block or sick-sinus syndrome without permanent pacemakerDiagnosed with acute coronary syndrome or treated with percutaneous coronary intervention within the last 3 monthsPatients with structural heart disease (moderate to severe aortic or mitral valve stenosis, interventricular septal thickness >15mm, congenital heart disease)Accepted cardiac surgery within the last 3 monthsLeft atrial diameter (LAD) >55 mmPatients with left atrial or left auricular thrombosisPatients with HyperthyroidismSevere dysfunction of liver and kidney diseases (ALT≥3ULN or eGFR<30ml/min/1.73m2)Abnormal blood coagulationConcomitant use of dabigatranConcomitant use of drugs that prolong QTc or may induce torsades de pointesConcomitant use of strong CYP3A inhibitorsConcomitant use of another Class IA, IC, or III AADsPatients suffering from serious infection, mental illness or malignant tumorsPregnancy or breast-feeding
Source: ClinicalTrials.gov (NCT05655468). StuddyBuddy aggregates publicly available trial information.