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Pulsed-Field Ablation With or Without Electrogram Mapping for Non-Paroxysmal Atrial Fibrillation

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Summary

NIH registered a prospective multicenter randomized controlled trial (NCT07541989) comparing two pulsed-field ablation strategies for non-paroxysmal atrial fibrillation: PFA-based pulmonary vein isolation plus posterior wall isolation alone versus the same approach plus adjunctive ablation guided by electrogram mapping of key substrates. The study aims to evaluate efficacy and safety in a broader clinical setting.

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What changed

NIH registered a new clinical trial on ClinicalTrials.gov. The trial (NCT07541989) will enroll patients with non-paroxysmal atrial fibrillation and randomly assign them to receive either PFA-based pulmonary vein isolation plus posterior wall isolation alone, or the same anatomical approach plus adjunctive ablation guided by electrogram mapping of key substrates. Prior single-center data suggested the adjunctive approach was feasible and improved rhythm outcomes.

Clinical investigators in cardiac electrophysiology may wish to monitor this study's outcomes, as findings could inform future ablation strategy selection for non-paroxysmal atrial fibrillation patients. The trial represents a multicenter validation of prior single-center feasibility findings.

Archived snapshot

Apr 22, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Pulsed-Field Ablation With/Without Electrogram Mapping

N/A NCT07541989 Kind: NA Apr 21, 2026

Abstract

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

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Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Ablation therapy research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices

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