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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Procedure: Anatomical Guided Ablation; Procedure: Extensive Electro-Anatomical Guided Ablation; Procedure: Electrogram Guided Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06739512

EXT-II

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 3 patient groups, including a placebo group

Anatomical Guided Ablation Group

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Anatomical Guided Ablation

Electrogram Guided Ablation Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Electrogram Guided Ablation

Extensive Electro-Anatomical Guided Ablation Group

Experimental group

Description:

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.

Treatment:

Procedure: Extensive Electro-Anatomical Guided Ablation