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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06145906
Enrollment
400
Registered
2023-11-24
Start date
2023-12-26
Completion date
2026-12-01
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, catheter ablation, optimized strategies and workflows

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.

Interventions

Pulmonary vein isolation plus superior vena cava isolation

PROCEDUREPVI, 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

Sponsors

Henan Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
AF recurrence12 monthsAny symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds after a 3-month blanking period

Secondary

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

Countries

China

Contacts

Primary ContactYingjie Chu
hnqbdsl@126.com+8613027736160

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026