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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dronedarone | Experimental | dronedarone 400mg twice a day for 9 months |
|
| placebo | Placebo Comparator | Placebo(for dronedarone ) a day for 9 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronedarone | Drug | oral administration fed conditions |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37155004 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077764 | Dronedarone |
| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
strictly identical in appearance with dronedarone,oral administration fed conditions |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |