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

Recruiting
Conditions
Atrial Fibrillation
Interventions
Procedure: Pulmonary vein isolation plus superior vena cava isolation
Procedure: 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
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

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
Arm && Interventions
GroupInterventionDescription
Paroxysmal AF groupPulmonary vein isolation plus superior vena cava isolationAF that terminates spontaneously or with intervention within 7 days of onset
Persistent AF groupPVI, 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 isthmusAF that is continuously sustained beyond 7 days, including episodes terminated by cardioversion (drugs or electrical cardioversion) after ≥7 days
Primary Outcome Measures
NameTimeMethod
AF recurrence12 months

Any symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds after a 3-month blanking period

Secondary Outcome Measures
NameTimeMethod
initial block rateintraoperation

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

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