Clinical trial NCT06145906: Application Value of Whole-procedure Optimization for Catheter Ablation of Atrial Fibrillation
Official title: Application Value of Whole-procedure Optimization for Catheter Ablation of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
catheter ablation
optimized strategies and workflows
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: There are ECG which can be definitely diagnosed as atrial fibrillation, that is: P wave disappeared, replaced by F wave, frequency 350-600 times / min, QRS wave rhythm is absolutely irregular, RR interval is uneven, QRS wave shape is normal

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.


Eligibility criteria: 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

Primary outcomes:
measure: AF recurrence
timeFrame: 12 months
Secondary outcomes:
measure: initial block rate
timeFrame: intraoperation
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Cardiology, Henan Provincial People's Hospital
state: Henan
Study officials:
References:
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