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A prospective multicenter randomized controlled trial comparing the efficacy of short-term and conventional use of antiarrhythmic drugs after pulsed ablation for paroxysmal atrial fibrillation

A prospective multicenter randomized controlled trial comparing the efficacy of short-term and conventional use of antiarrhythmic drugs after pulsed ablation for paroxysmal atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104017
Enrollment
Unknown
Registered
2025-06-10
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

paroxysmal atrial fibrillation

Interventions

Intervention group:1 month postoperatively, class I or class III antiarrhythmic drugs were used, except for amiodarone
Control group:Routine use of class I or III antiarrhythmic drugs for 3 months after surgery, except amiodarone

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years or older; 2.Patients diagnosed with paroxysmal atrial fibrillation and planning to undergo pulsed ablation; 3.Patients undergoing the first ablation treatment for atrial fibrillation this time; 4.Patients who can and are willing to wear an electrocardiogram monitoring device during the study and upload the data; 5.Patients who can and are willing to provide the specified observational data and/or participate in the baseline and follow-up assessments of the entire study.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with persistent atrial fibrillation; 2. Patients with atrial fibrillation secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible/non-cardiac causes; 3. Patients, according to the investigator's judgment, who have any known contraindications for pulse ablation system, anticoagulation therapy or contrast agent use and atrial fibrillation ablation; 4. Any patients who have known inability to obtain vascular access or have contraindications for femoral vein puncture; 5. Patients with any of the following atrial heart diseases: a. Left atrial (LA) anterior-posterior diameter >= 5.5 cm measured by transthoracic echocardiography (TTE) within 3 months before surgery; b. Any previous atrial endocardial, epicardial or surgical ablation surgery for arrhythmia, except for right tricuspid isthmus ablation or right supraventricular tachycardia; c. Current atrial myxoma or left atrial thrombus; d. Any pulmonary vein abnormality, stenosis or stent implantation (including common pulmonary veins and middle pulmonary veins); 6. Patients with cardiovascular events in the past 3 months (including acute myocardial infarction, coronary intervention, coronary artery bypass surgery, artificial valve replacement or repair, atrial or ventricular incision); 7. Patients with heart failure diagnosed by transthoracic echocardiography within 3 months before surgery with left ventricular ejection fraction < 40%; 8. Patients undergoing or expected to undergo implantation of pacemaker, implantable cardioverter-defibrillator and cardiac resynchronization therapy device and through atrial septal patch or barrier for atrial septal defect closure or patent foramen ovale closure; 9. Patients for whom I/III class anti-arrhythmic drugs cannot be discontinued due to non-atrial rhythm causes; 10. Patients according to the investigator's judgment, with an expected life expectancy of less than one year before surgery; 11. Pregnant patients.

Design outcomes

Primary

MeasureTime frame
Long-term success rate;

Secondary

MeasureTime frame
Treatment success rate;Atrial fibrillation burden;The proportion of participants with a fibrillation load greater than 0.1%;The incidence rate of major complications;

Countries

China

Contacts

Public ContactRui Zeng

West China Hospital of Sichuan University

zengrui_0524@126.com+86 189 8060 6560

Outcome results

None listed

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