Back to resultsEffect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation (DORIS)
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dronedarone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring dronedarone, placebo, non-paroxysmal atrial fibrillation, ablation
Eligibility Criteria
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
Sites / Locations
- Shanghai East HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dronedarone
placebo
Arm Description
dronedarone 400mg twice a day for 9 months
Placebo(for dronedarone ) a day for 9 months
Outcomes
Primary Outcome Measures
cumulative nonrecurrence rate
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
drug withdrawal due to intolerance to or persistent AA(lasting more than 7 days)
time to first recurrence
cardioversion due to recurrence
repeat ablation due to recurrence
unscheduled visit and rehospitalization due to recurrence
Full Information
NCT ID
NCT05655468
First Posted
December 7, 2022
Last Updated
April 11, 2023
Sponsor
Shanghai East Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05655468
Brief Title
Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation
Acronym
DORIS
Official Title
Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai East Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
dronedarone, placebo, non-paroxysmal atrial fibrillation, ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dronedarone
Arm Type
Experimental
Arm Description
dronedarone 400mg twice a day for 9 months
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo(for dronedarone ) a day for 9 months
Intervention Type
Drug
Intervention Name(s)
Dronedarone
Intervention Description
oral administration fed conditions
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
strictly identical in appearance with dronedarone,oral administration fed conditions
Primary Outcome Measure Information:
Title
cumulative nonrecurrence rate
Description
defined as any atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia) recorded by electrocardiogram (ECG)>30s
Time Frame
post 3 to 12 months after ablation
Secondary Outcome Measure Information:
Title
drug withdrawal because of side effect
Time Frame
post 3 to 12 months after ablation
Title
drug withdrawal due to intolerance to or persistent AA(lasting more than 7 days)
Time Frame
post 3 to 12 months after ablation
Title
time to first recurrence
Time Frame
post 3 to 12 months after ablation
Title
cardioversion due to recurrence
Time Frame
post 3 to 12 months after ablation
Title
repeat ablation due to recurrence
Time Frame
post 3 to 12 months after ablation
Title
unscheduled visit and rehospitalization due to recurrence
Time Frame
post 3 to 12 months after ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shanghai East Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Yang, MD
Phone
+86-18117141291
Email
ybheart@163.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation
We'll reach out to this number within 24 hrs