Pulsed-Field Ablation With/Without Electrogram Mapping

Conditions

• Non-paroxysmal Atrial Fibrillation

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates — PROCEDURE
  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.
• PFA-based PVI+PWI alone — PROCEDURE
  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.

Study Details

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.

Key Dates

Start date

Sep 30, 2024

Status verified

Apr 2026

Primary completion

May 1, 2028

Completion

Jun 1, 2028

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: EGM
  PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates: Participants randomized to this arm will undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI), followed by adjunctive ablation targeting key atrial substrates identified by predefined electrogram mapping criteria.
• Active Comparator: PWI
  Participants randomized to this arm will undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI) without adjunctive ablation guided by electrogram mapping of key substrates.

Primary Outcome Measure

freedom from any AF/AT [ Time Frame: freedom from any AF/AT at 3 months, 6 months, 12 months and 36 months respectively after the procedure; adverse events occurring within 30 days of the index or reassessment procedures. ]

Locations (1)

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