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NCT Number: NCT06145906

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location status: Recruiting

Location contact

Yingjie Chu

CONTACT

[email protected]

+8613027736160

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary vein isolation plus superior vena cava isolation

Procedure

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

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

Primary outcomes

  1. AF recurrence

    Time frame: 12 months

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

Secondary outcomes

  1. initial block rate

    Time frame: intraoperation

    initial block rate of pulmonary veins isolation, superior vena cava isolation and additional ablation lines

Study contacts

Contact information is provided by the study sponsor or research team.

Yingjie Chu

CONTACT

[email protected]

+8613027736160

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2023
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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