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

NCT05655468 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2023-04-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dronedarone

oral administration fed conditions

DRUG

Placebo

strictly identical in appearance with dronedarone,oral administration fed conditions

Sponsors & Collaborators

  • Shanghai East Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2025-04-30
Completion
2025-11-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05655468 on ClinicalTrials.gov