Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06739512
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-24
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Start: 2024-12-25
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

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 and Quality of Life Enhancement.	From enrollment to completion of follow-up（at least 12 months）	Improvement in clinical symptoms (EHRA score) and quality of life measurements (Short Form 36 HealthSurvey).
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