NCT05655468

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
268

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 29, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

December 7, 2022

Last Update Submit

April 11, 2023

Conditions

Atrial Fibrillation

Keywords

dronedaroneplacebonon-paroxysmal atrial fibrillationablation

Outcome Measures

Primary Outcomes (1)

  • cumulative nonrecurrence rate

    defined as any atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia) recorded by electrocardiogram (ECG)\>30s

    post 3 to 12 months after ablation

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

dronedarone

EXPERIMENTAL

dronedarone 400mg twice a day for 9 months

Drug: Dronedarone

placebo

PLACEBO COMPARATOR

Placebo(for dronedarone ) a day for 9 months

Drug: Placebo

Interventions

DronedaroneDRUG

oral administration fed conditions

dronedarone
PlaceboDRUG

strictly identical in appearance with dronedarone,oral administration fed conditions

placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital

Shanghai, China

RECRUITING

Related Publications (1)

  • Wu Y, Fan F, Yu J, Zhou J, Xie X, Xia G, Zhong D, Cheng D, Zhang B, Wang X, Chen Z, Wang S, Li X, Yang B. Effect of Prolonged Use of Dronedarone on Recurrence in Patients with Non-Paroxysmal Atrial Fibrillation After Radiofrequency Ablation (DORIS): Rationale and Design of a Randomized Multicenter, Double-Blinded Placebo-Controlled Trial. Cardiovasc Drugs Ther. 2024 Oct;38(5):1047-1052. doi: 10.1007/s10557-023-07460-1. Epub 2023 May 8.

    PMID: 37155004DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dronedarone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmiodaroneBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy director of cardiovascular department

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 19, 2022

Study Start

March 29, 2023

Primary Completion

April 1, 2025

Study Completion

November 1, 2025

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

CN(1)