NCT06739512

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

Efficacy and Safety of Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation: a Multicenter Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
PROCEDURE	Extensive Electro-Anatomical Guided Ablation	Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques.
PROCEDURE	Anatomical Guided Ablation	Ablation using PFA. Guided by anatomical landmarks without potential mapping
PROCEDURE	Electrogram Guided Ablation	Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter.

Timeline

• Start date: 2024-12-25
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-12-18
• Last updated: 2024-12-18

Locations

1 site across 1 country: China