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A multicenter, randomized controlled clinical study of oral dronedarone hydrochloride tablets after catheter ablation in patients with persistent atrial fibrillation to reduce the first recurrence of atrial fibrillation

A multicenter, randomized controlled clinical study of oral dronedarone hydrochloride tablets after catheter ablation in patients with persistent atrial fibrillation to reduce the first recurrence of atrial fibrillation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052758
Enrollment
Unknown
Registered
2021-11-05
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-08-16

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

Conditions

Atrial fibrillation

Interventions

Experimental group:Dronedarone Hydrochloride Tablets

Sponsors

Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years diagnosed with persistent atrial fibrillation with a duration of <3 years; 2. All patients received catheter ablation and recovered sinus rhythm after ablation; 3. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of allergy to dronedarone or amiodarone; 2. Patients with New York Heart Association class III/IV heart failure or recent cardiac decompensation requiring hospitalization; 3. First-degree AV block with PR interval > 280 ms, or second- or third-degree AV block, or patients with sick sinus syndrome (unless a pacemaker is installed); 4. Patients with bradycardia (average heart rate = 500 ms, or concomitant use of medicinal or natural medicines that prolong the QT interval and may increase the risk of torsades de pointes, such as phenothiazine antipsychotics, tricyclic antidepressants, some oral macrolide antibiotics; 7. Liver function: AST and ALT > 2.5 times the upper limit of normal; total bilirubin > 1.5 times the upper limit of normal; previous hypersensitivity pneumonitis or interstitial pneumonitis associated with amiodarone use; 8. Amiodarone was used within 4 weeks before ablation, or other antiarrhythmic drugs were discontinued for less than 5 half-lives before ablation; 9. Severe electrolyte abnormalities (serum potassium <3.5mmol/L, serum magnesium <0.75mmol/L); 10. Obstructive/occult obstructive hypertrophic cardiomyopathy.

Design outcomes

Primary

MeasureTime frame
The first recurrence of atrial fibrillation/atrial tachycardia within 3 months after surgery lasted > 30 seconds;

Secondary

MeasureTime frame
Atrial fibrillation (AF) load;Assessment of quality of life in patients with atrial fibrillation.;

Countries

China

Contacts

Public ContactYao Yan

Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences

ianyao@263.net.cn+86 755 82180028

Outcome results

None listed

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