Comparative Efficacy and Safety of Extensive Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in Persistent Atrial Fibrillation

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06745167
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

This multicenter, randomized controlled trial aims to compare the efficacy and safety of extensive electro-anatomical guided pulsed field ablation (EXT-PFA) with traditional radiofrequency ablation (RF) in treating persistent atrial fibrillation (PeAF). The trial seeks to determine if EXT-PFA, which integrates anatomical and electrogram-guided strategies, can provide superior outcomes in terms of safety and effectiveness compared to the standard RF ablation approach.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Start: 2025-01-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1.Adults aged 18-80 years diagnosed with persistent atrial fibrillation. 2.Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.

Exclusion Criteria

1. Major valvular diseases needing surgical intervention.
2. Presence of a left atrial thrombus on recent imaging.
3. Recent myocardial infarction or severe heart failure (LVEF ≤ 30%).
4. Current Severe Infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom from Atrial Arrhythmia Recurrence at 12 Months	12 months after ablation procedure	Proportion of participants free from atrial fibrillation/atrial flutter/atrial tachycardia recurrence at 12 months post-ablation.

Secondary Outcome Measures

Name	Time	Method
Procedural Safety	From enrollment to completion of follow-up（at least 12 months）	Incidence of procedural complications such as esophageal injury and pulmonary vein stenosis.
Symptom Relief (EHRA scores)	From enrollment to completion of follow-up（at least 12 months）	Improvement in clinical symptoms (EHRA scores)
Quality of Life (Short Form 36 Health Survey).	From enrollment to completion of follow-up（at least 12 months）	quality of life measurements (Short Form 36 Health Survey).
Atrial Fibrillation Burden Reduction	From enrollment to completion of follow-up（at least 12 months）	Reduction in atrial fibrillation burden assessed through follow-up evaluations.

Trial Locations

Locations (1)

No. 241, West Huaihai Road; 🇨🇳 Shanghai, Shanghai, China