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Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

NCT06791629 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-02-15
Last updated
2025-01-24

Condition(s) studied

Persistent Atrial FibrillationRadiofrequency Catheter AblationPulsed Field Ablation

Investigational drug(s) / intervention(s)

Pulsed Field AblationRadiofrequency Ablation

Pulsed Field Ablation: Patients will be treated with pulsed field ablation for atrial fibrillation.

Radiofrequency Ablation: Patients will be treated with radiofrequency ablation for atrial fibrillation.

Study summary

This clinical trial aims to compare the efficacy and safety of pulsed field ablation and radiofrequency ablation to treat persistent atrial fibrillation in adults.

Participants will:

Undergo pulsed field ablation or radiofrequency ablation. Keep follow-up for at least 12 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18-80 years * Patients with non-valvular persistent atrial fibrillation undergoing their first catheter ablation (AF duration: 3 months to 3 years) * Left atrial diameter on parasternal long-axis view of echocardiogram \< 50 mm * Agree to be randomly assigned to the ablation strategy and able to follow up Exclusion Criteria: * Atrial fibrillation due to reversible causes * LVEF \< 30% * Severe congenital heart disease * Severe liver or kidney dysfunction (eGFR \< 15, Child-Pugh grade 3), or history of dialysis * History of cardiac surgery, such as coronary artery bypass grafting, mechanical valve or prosthetic valve replacement * History of pacemaker implantation, left atrial appendage closure, or patent foramen ovale closure * Contraindications to oral anticoagulation * Contraindications to right or left heart catheterization * Pregnancy * Life expectancy \< 1 year (e.g., advanced malignancy, end-stage renal disease) * Currently enrolled in another trial evaluating medical devices or drugs * Other situations where the investigator determines the subject is unsuitable for the study

Primary outcome measure(s)

  • Freedom from any documented atrial arrhythmia lasting for >30s in the absence of antiarrhythmic therapy in 12 months after the index ablation procedure (excluding a blanking period of 3 months) — From the end of the 3-month blanking period post-ablation to the 12-month follow-up

Trial sites (1)

FacilityCityRegionStatus
Beijing Anzhen Hospital, Capital Medical University Beijing China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06791629 on ClinicalTrials.gov ↗ ← All trials in China