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Pulsed-Field Ablation With/Without Electrogram Mapping

NCT07541989 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-21

No results posted yet for this study

Summary

Pulsed field ablation (PFA) has demonstrated favorable safety and efficacy in atrial fibrillation ablation, particularly for pulmonary vein isolation (PVI). However, the optimal PFA-based ablation strategy for non-paroxysmal atrial fibrillation remains uncertain. In addition to anatomical lesion sets such as PVI and posterior wall isolation (PWI), Electrogram Mapping of Key Substrates may allow identification of residual arrhythmogenic areas that contribute to the maintenance of atrial fibrillation. In the investigators' previously completed single-center cohort study, adjunctive ablation targeting key substrates identified by electrogram mapping on top of PVI+PWI was feasible and associated with improved rhythm outcomes.

This prospective multicenter randomized controlled study is designed to compare PFA-based PVI+PWI alone versus PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates in patients with non-paroxysmal atrial fibrillation, in order to evaluate the efficacy and safety of this strategy in a broader and more rigorous clinical setting.

Conditions

  • Non-paroxysmal Atrial Fibrillation

Interventions

PROCEDURE

PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates

In the experimental arm, electrogram mapping will be performed before pulmonary vein isolation (PVI) and posterior wall isolation (PWI) to identify key atrial substrates for adjunctive ablation. Mapping may be conducted using machine learning-assisted electrogram mapping, operator-guided electrogram mapping, or a combination of both, based on the same predefined criteria for target identification. Electrogram analysis will then be performed to identify target regions with the following characteristics: 1)Spatial-temporal dispersion activation; 2)Short cycle length activity; 3)Focal activity. After completion of electrogram mapping and target identification, all participants in the experimental arm will undergo standard PFA-based PVI and PWI. Adjunctive pulsed-field ablation will subsequently be delivered to the electrogram-defined key substrates identified during the pre-ablation mapping phase.

PROCEDURE

PFA-based PVI+PWI alone

Ablation will be performed using a pulsed-field ablation system. Participants in this arm will undergo standard pulmonary vein isolation and posterior wall isolation only, without additional substrate ablation guided by electrogram mapping.

Sponsors & Collaborators

  • Shanghai Chest Hospital, Shanghai Jiao Tong University School Of Medicine

    collaborator UNKNOWN

  • Xu Liu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2028-05-01
Completion
2028-06-01

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07541989 on ClinicalTrials.gov