Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

N/ANot Yet RecruitingNCT06791629

Beijing Anzhen Hospital700 enrolled

Overview

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.

Traditional treatment options for persistent atrial fibrillation (PeAF) include pharmacological management, electrical cardioversion, and catheter ablation. Pulmonary vein isolation (PVI) has become the cornerstone of ablation therapy and has been shown to be effective in clinical practice. However, its efficacy is relatively limited in patients with persistent AF compared with those with paroxysmal AF, and many patients still experience recurrence after treatment. In recent years, linear ablation strategies based on alcohol ablation have been shown to improve the one-year maintenance of sinus rhythm in patients with PeAF. Traditional radiofrequency ablation (RF) has demonstrated good outcomes but still has certain limitations when dealing with PeAF. In several clinical studies, pulsed field ablation (PFA), an emerging and innovative technique, has shown non-inferiority in treating paroxysmal AF. Furthermore, PFA has also demonstrated significant efficacy in linear ablation sites such as the mitral isthmus line, posterior left atrial wall, and tricuspid isthmus line, highlighting its potential in treating PeAF. This study aims to compare the safety and efficacy of PFA and radiofrequency ablation (RF) in the treatment of PeAF through a multi-center, prospective, randomized, open-label, non-inferiority clinical trial, to provide a safer and more effective treatment option for clinical practice.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

700

Conditions

Persistent Atrial Fibrillation Radiofrequency Catheter Ablation Pulsed Field Ablation

Interventions

Pulsed Field AblationDEVICE

Patients will be treated with pulsed field ablation for atrial fibrillation.

Radiofrequency AblationDEVICE

Patients will be treated with radiofrequency ablation for atrial fibrillation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

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)