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

NCT06739512 | Not Yet Recruiting DMC

• 1 other identifier: EXT-II
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF)

Keywords

ablation; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Procedural Safety

  From enrollment to completion of follow-up（at least 12 months）

• Symptom Relief and Quality of Life Enhancement.

  From enrollment to completion of follow-up（at least 12 months）

• Atrial Fibrillation Burden Reduction

  From enrollment to completion of follow-up（at least 12 months）

Study Arms (3)

Anatomical Guided Ablation Group

PLACEBO COMPARATOR

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

Electrogram Guided Ablation Group

ACTIVE COMPARATOR

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

Extensive Electro-Anatomical Guided Ablation Group

EXPERIMENTAL

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

Interventions

Extensive Electro-Anatomical Guided Ablation PROCEDURE

Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques.

Extensive Electro-Anatomical Guided Ablation Group

Anatomical Guided Ablation PROCEDURE

Ablation using PFA. Guided by anatomical landmarks without potential mapping

Anatomical Guided Ablation Group

Electrogram Guided Ablation PROCEDURE

Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter.

Electrogram Guided Ablation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

No. 241, West Huaihai Road

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xu Liu, MD

CONTACT

+86 021-22200000; drliuxu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 18, 2024
• Study Start: December 25, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)