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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHenan Provincial People's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Radiofrequency catheter ablation for the first time

AF rhythm recorded by ECG

Disqualifiers

Thrombosis in left atrium

Left ventricular ejection fraction of < 35%

Abnormal thyroid function

Previous history of AF radiofrequency ablation and CABG

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pulmonary vein isolation plus superior vena cava isolation

    Procedure/Surgery

    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/Surgery

    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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Paroxysmal AF group1 intervention
Group B: Persistent AF group1 intervention

Trial outcomes

Primary outcomes

1

AF recurrence

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

Time frame
12 months

Secondary outcomes

1

initial block rate

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

Time frame
intraoperation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.