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

Efficacy and Safety of Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation: a Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Procedure: Anatomical Guided Ablation; Procedure: Electrogram Guided Ablation; Procedure: Extensive Electro-Anatomical Guided Ablation

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xu Liu, MD; Phone Number: +86 021-22200000; Email: drliuxu@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • No. 241, West Huaihai Road
      • Contact: Xu Liu, MD; Phone Number: +86 021-22200000; Email: drliux@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Anatomical Guided Ablation Group; This group will undergo pulmonary vein isolation (PVI) combined with anatomical linear ablation based on predefined anatomical landmarks (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification), including lines such as the mitral isthmus and roofline. The ablation will aim to create bidirectional block without relying on electrogram-based mapping.	Procedure: Anatomical Guided Ablation; Ablation using PFA. Guided by anatomical landmarks without potential mapping
Active Comparator: Electrogram Guided Ablation Group; This group will undergo PVI and targeted ablation of atrial fibrillation "drivers" identified through electrogram-guided mapping. The mapping will focus on electrograms with characteristics such as spatial-temporal dispersion, high-frequency potentials, and short local cycle lengths.	Procedure: Electrogram Guided Ablation; Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter.
Experimental: Extensive Electro-Anatomical Guided Ablation Group; This group will receive PVI and a combination of anatomical linear ablation (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification) and electrogram-guided ablation. It represents an extensive strategy that integrates both anatomical and potential-based mapping for optimized ablation targeting.	Procedure: Extensive Electro-Anatomical Guided Ablation; Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Collaborators: Xuzhou Central Hospital; Shandong University of Traditional Chinese Medicine; Changshu Hospital of Traditional Chinese Medicine; Yuhuan Second People's Hospital; The PLA Navy Anqing Hospital; Albert Einstein College of Medicine and Montefiore Medical Center; Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine; Jinan People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 25, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: atrial fibrillation; ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: EXT-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No