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NOT YET RECRUITING
NCT07880262
NA

Efficacy and Safety of Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping for Atrial Fibrillation

Sponsor: Xi'an Jiaotong University

View on ClinicalTrials.gov

Summary

This study will adopt a prospective, single-center, single-arm research design, enrolling 120 patients with paroxysmal or persistent atrial fibrillation who are scheduled to undergo catheter ablation for the first time. Individualized pulsed electrical field pulmonary vein isolation will be performed under the guidance of pulmonary vein vestibular stromal mapping. By recording the distribution characteristics of abnormal stroma in the pulmonary vein vestibule, the guidance situation of the ablation strategy based on the mapping results, surgical and ablation parameters, immediate pulmonary vein isolation effect, perioperative complications, and the 12-month recurrence-free survival rate of atrial arrhythmias after surgery, the feasibility, effectiveness and safety of this ablation strategy will be evaluated, and the relationship between the characteristics of pulmonary vein vestibular stroma and postoperative recurrence will be explored. This will provide more clinical experience and data support for individualized ablation under the guidance of pulmonary vein vestibular stromal mapping.

Official title: Efficacy and Safety of Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping for Atrial Fibrillation: A Prospective, Single-Center, Single-Arm Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-11-01

Completion Date

2028-12-01

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

PROCEDURE

Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping

Before ablation, electroanatomic voltage mapping of the left atrium and pulmonary vein antra will be performed. Low-voltage areas will be identified using prespecified thresholds according to the rhythm during mapping: \<0.5 mV during sinus rhythm and \<0.3 mV during atrial fibrillation. Mapping findings will guide an individualized pulmonary vein isolation strategy, including the ablation boundary and segmental lesion delivery, according to the study protocol. Pulsed field energy will be delivered using the PFA catheter and system specified in the protocol. Repeat mapping will be performed 20-30 minutes after ablation to assess the lesion set and identify residual conduction or reconnection.