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Clinical Trials in China / NCT06145906
Recruiting Observational

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

NCT06145906 · tracked via the Priya Life Science China tracker
Sponsor
Henan Provincial People's Hospital
Phase
Observational
Started
2023-12-26
Last updated
2024-03-18

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Pulmonary vein isolation plus superior vena cava isolationPVI, 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

Pulmonary vein isolation plus superior vena cava isolation: Pulmonary vein isolation plus superior vena cava isolation

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: 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

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Cardiology, Henan Provincial People's Hospital Zhengzhou Henan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06145906 on ClinicalTrials.gov ↗ ← All trials in China