Application Value of Whole-procedure Optimization for Catheter Ablation of Atrial Fibrillation

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT06145906
• Lead Sponsor: Henan Provincial People's Hospital

Brief Summary

The success rate of single-procedure atrial arrhythmia-free survival particularly ranged from 40% to 66% in persistent AF ablation. However, The surgical Cox maze III procedure has been established to be an effective curative strategy for AF with an AF-free survival rate of more than 95%. The main reason is the difficulty of creating continuous, transmural, and durable lesions by catheter ablation, especially when the procedure is performed on some complex anatomical structures in which epicardial muscular bundles may serve as components of the reentrant circuits.

The durability of the conduction block is a crucial factor for long-term effective AF ablation since previous studies reported that the reconnected Pulmonary veins contributed to the atrial tachycardia recurrence after persistent AF ablation. In addition, it is possible that the inadequate lesions accidentally produce new arrhythmogenic substrates. Therefore, new and better techniques are always chosen to minimize the reconnection of Pulmonary vein isolation (PVI) and additional ablation.

For paroxysmal AF, the ablation strategy of PVI plus superior vena cava isolation is chosen while PVI, superior vena cava isolation, and linear ablation of linear ablations of the mitral isthmus, roofline and posterior wall line of the left atrium, and cavotricuspid isthmus (CTI) for persistent AF. Any symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds was regarded as an AF recurrence after a 3-month blanking period. The primary outcome was defined as 12-month atrial arrhythmia-free survival. The secondary outcomes include the block rate of PVI, superior vena cava isolation, and all linear ablations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Study Start: 2023-12-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Radiofrequency catheter ablation for the first time
• AF rhythm recorded by ECG

Exclusion Criteria

• Thrombosis in left atrium
• Left ventricular ejection fraction of < 35%
• Abnormal thyroid function
• Previous history of AF radiofrequency ablation and CABG
• Left atrium diameter of > 65 mm or the volume of > 200 ml

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AF recurrence	12 months	Any symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds after a 3-month blanking period

Secondary Outcome Measures

Name	Time	Method
initial block rate	intraoperation	initial block rate of pulmonary veins isolation, superior vena cava isolation and additional ablation lines

Trial Locations

Locations (1)

Department of Cardiology, Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China