Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-01 @ 12:19 PM
Study NCT ID:
NCT06729866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EGM Guided PFA for PerAF
Sponsor:
Xu Liu
Organization:
Study Overview
Official Title:
Electrogram Guided Pulse Field Ablation for Persistent Atrial Fibrillation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EGM-PFA
Brief Summary:
Pulse field ablation (PFA) has shown safety and efficacy in paroxysmal atrial fibrillation (AF), while the application in persistent atrial fibrillation (PerAF) is still under investigation. The investigators' previous randomized controlled trial showed favorable outcomes with electrogram (EGM) guided radiofrequency ablation in PerAF. However, EGM-guided PFA has not yet been reported.
Detailed Description:
Multiple studies have confirmed that pulse field ablation (PFA) demonstrates superior safety and efficacy in pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF). However, the application of PFA in persistent atrial fibrillation (PerAF) remains in the exploratory stages. The efficacy and safety of PFA across various ablation strategies require a comprehensive evaluation. Notably, electrogram (EGM) guided PFA ablation for persistent atrial fibrillation has not yet been reported in the literature.
In the investigators' previous study on radiofrequency ablation for PerAF, the investigators observed that EGM guided ablation yielded a high success rate. Furthermore, the investigators' recent research has confirmed that intraoperative termination of atrial fibrillation using EGM guided ablation is associated with favorable long-term outcomes in patients with PerAF.
The investigators aim to explore the preliminary application of EGM guided pulse field ablation (PFA) in persistent atrial fibrillation.
In the investigators' previous study on radiofrequency ablation for PerAF, the investigators observed that EGM guided ablation yielded a high success rate. Furthermore, the investigators' recent research has confirmed that intraoperative termination of atrial fibrillation using EGM guided ablation is associated with favorable long-term outcomes in patients with PerAF.
The investigators aim to explore the preliminary application of EGM guided pulse field ablation (PFA) in persistent atrial fibrillation.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: