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

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

Sponsor
Xi'an Jiaotong University (Academic or other)
Enrollment
120 planned
Conditions
Atrial Fibrillation (AF)
Interventions
Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping
Ages
adults, older adults
Registry
NCT07880262

Full record on ClinicalTrials.gov

From the registry

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…

Primary outcomes

  • Freedom From Atrial Tachyarrhythmia Recurrence

History

  1. Primary completion expected

  2. Started

  3. Last registry update

  4. Registered