DORIS: Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation

Sponsor

Shanghai East Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05655468

Collaborator

(none)

268

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Dronedarone Drug: Placebo	Phase 4

Detailed Description

In this multicenter, randomized, placebo-controlled trial, patients with non-paroxysmal AF will receive dronedarone for three months after radiofrequency ablation. Eligible Patients will then be randomly divided into dronedarone and placebo groups and followed up until one year after ablation. The primary endpoint is the cumulative nonrecurrence rate post three months and within one year after ablation. 7-day Holter monitoring (ECG patch) will be scheduled at 6,9, and 12 months after ablation for evaluating AA recurrence. Secondary endpoints include dronedarone withdrawal due to side effect or intolerance of AA recurrence, time to the first recurrence, repeat ablation, electrical cardioversion, unscheduled visit ,and rehospitalization.

This trial will evaluate whether prolonged use of dronedarone effectively reduces recurrence rate after ablation in non-paroxysmal AF patients. The result of this trial will provide evidence for optimizing post-ablation anti-arrhythmic therapy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

268 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dronedarone dronedarone 400mg twice a day for 9 months	Drug: Dronedarone oral administration fed conditions
Placebo Comparator: placebo Placebo(for dronedarone ) a day for 9 months	Drug: Placebo strictly identical in appearance with dronedarone,oral administration fed conditions

Arm

Intervention/Treatment

Experimental: dronedarone

dronedarone 400mg twice a day for 9 months

Drug: Dronedarone

oral administration fed conditions

Placebo Comparator: placebo

Placebo(for dronedarone ) a day for 9 months

Drug: Placebo

strictly identical in appearance with dronedarone,oral administration fed conditions

Outcome Measures

Primary Outcome Measures

cumulative nonrecurrence rate [post 3 to 12 months after ablation]
defined as any atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia) recorded by electrocardiogram (ECG)>30s

Secondary Outcome Measures

drug withdrawal because of side effect [post 3 to 12 months after ablation]
drug withdrawal due to intolerance to or persistent AA(lasting more than 7 days) [post 3 to 12 months after ablation]
time to first recurrence [post 3 to 12 months after ablation]
cardioversion due to recurrence [post 3 to 12 months after ablation]
repeat ablation due to recurrence [post 3 to 12 months after ablation]
unscheduled visit and rehospitalization due to recurrence [post 3 to 12 months after ablation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 18-80 years;
Diagnosis of non-paroxysmal AF
Undergoing AF ablation for the first time

Exclusion Criteria:

Unwilling to take or intolerant to dronedarone;
Hypersensitivity to the drug ingredient
Patients with decompensated heart failure, class NYHA IV, or left ventricular ejection fraction (LVEF) ≤40%
Bradycardia <50 bpm
QTc Bazett interval ≥500ms or PR interval >280ms
II or III atrioventricular (AV) block or sick-sinus syndrome without permanent pacemaker
Diagnosed with acute coronary syndrome or treated with percutaneous coronary intervention within the last 3 months
Patients 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 months
Left atrial diameter (LAD) >55 mm
Patients with left atrial or left auricular thrombosis
Patients with Hyperthyroidism
Severe dysfunction of liver and kidney diseases (ALT≥3ULN or eGFR<30ml/min/1.73m2)
Abnormal blood coagulation
Concomitant use of dabigatran
Concomitant use of drugs that prolong QTc or may induce torsades de pointes
Concomitant use of strong CYP3A inhibitors
Concomitant use of another Class IA, IC, or III AADs
Patients suffering from serious infection, mental illness or malignant tumors
Pregnancy or breast-feeding