Comparison of the effectiveness and safety of dronedarone and amiodarone for preventing atrial fibrillation recurrence after catheter ablation: an open label study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200066977

Enrollment

Unknown

Registered

2022-12-22

Start date

2023-01-01

Completion date

Unknown

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Interventions

Dronedarone group:Dronedarone

Amidarone group:Amidarone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Conform to the diagnostic criteria of paroxysmal atrial fibrillation or persistent atrial fibrillation; (2) Conforming to the conditions of catheter ablation for atrial fibrillation; (3) Understand the research process, agree to participate in this trial, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Use amiodarone or dronedarone in the last month; (2) Known hypersensitivity to any component of the test drug or serious complications; (3) Pregnant or lactating women; (4) Having malignant tumor; (5) Severe liver injury; (6) Hyperthyroidism (except those who have been cured); (7) ECG QT interval = 500ms; (8) Those who are participating in other clinical trials; (9) Permanent atrial fibrillation; (10) NYHA Grade IV symptomatic heart failure; (11) Patients with grade II or III atrioventricular block or sick sinus syndrome (unless a normal pacemaker is installed); (12) Patients with heart rate less than 50 beats per minute; (13) Those who use powerful CYP3A inhibitors, such as ketoconazole, itraconazole, voriconazole, environment-friendly mycin, clarithromycin, etc; (14) The concomitant use of drugs or natural drugs that can prolong the QT interval and may increase the risk of torsades de pointes, such as tricyclic antidepressants, phenothiazine antipsychotics, some oral macrolides and Class I/III antiarrhythmic drugs; (15) Those who plan to use dabigatran or rivalsaban for anticoagulation after catheter ablation.

Design outcomes

Primary

Measure	Time frame
Late recurrence;	—

Secondary

Measure	Time frame
Cardio cerebral vascular events;Cardiovascular death;All cause death;Cardiovascular readmission;Early recurrence;	—

Countries

China

Contacts

Public ContactJian Yang

Zhejiang University School of Medicine

1313027@zju.edu.cn15988878549

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026