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The Impact of Autonomic Function on Atrial Fibrillation Recurrence After Pulmonary Vein Ablation

The Impact of Autonomic Function on Recurrence Following Circumferential Pulmonary Vein Ablation for Atrial Fibrillation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06202209
Enrollment
100
Registered
2024-01-11
Start date
2023-09-13
Completion date
2024-10-30
Last updated
2024-01-11

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

Conditions

Atrial Fibrillation Recurrent

Keywords

Atrial Fibrillation Recurrent, Early recurrent atrial arrhythmia, Cardioneuroablation, Automatic function

Brief summary

This is a prospective and observational study. The investigator speculated that the use of DC in patients with paroxysmal AF can serve as a predictor for early and late AF recurrence following CPVI.

Detailed description

Atrial fibrillation (AF), also known as atrial flutter, is one of the most common cardiac arrhythmias and poses a serious threat to patients' health and well-being. The mechanism of AF is complex, with the autonomic nervous system playing a crucial role in its initiation and maintenance. Currently, medication and ablation are the main treatment methods to reduce AF episodes, but the efficacy of drug therapy is limited, and recurrence after ablation still exists. Recent studies have found that changes in autonomic nervous system activity are one of the key factors contributing to AF recurrence after ablation. Therefore, by objectively assessing changes in autonomic nervous system activity, it is expected to improve the success rate of AF ablation and provide a potential cure for AF, with significant social and economic value. Studies have found that pulmonary vein isolation (PVI) ablation is the mainstream method for AF ablation, and it affects the autonomic nervous system function. Patients who show significant changes in autonomic nervous system function after AF ablation have higher success rates. Additionally, early-onset atrial arrhythmias are closely related to long-term AF recurrence after ablation. However, the mechanisms underlying early recurrence still require further investigation. Our research team has conducted in-depth studies on the regulation of autonomic nervous system function in the heart and non-invasive assessment techniques, achieving breakthrough progress. The left atrial ganglion plays a crucial role in the initiation and maintenance of AF, and ablating the ganglion can improve the success rate of AF ablation. Non-invasive assessment techniques such as heart rate deceleration can quantitatively evaluate changes in vagal nerve activity in the heart, which can be used to predict the efficacy of autonomic ganglion intervention therapy. Based on the above research, our research team hypothesizes that precise and quantitative assessment of autonomic nervous system function using heart rate deceleration can predict AF recurrence after PVI ablation. To validate this hypothesis, we plan to conduct a prospective observational study, recruiting patients with paroxysmal AF, assessing changes in autonomic nervous system function, monitoring early-onset atrial arrhythmias and AF recurrence, and providing theoretical support for the screening and intervention of high-risk recurrence patients, laying a foundation for clinical application.

Interventions

Circumferential pulmonary vein isolation (CPVI) is a type of cardiac ablation procedure. Cardiac ablation procedures involve creating small scars in the heart using thermal or cold energy to block irregular electrical signals and restore normal heart rhythm. CPVI specifically creates small scars in the area where the four pulmonary veins connect to the left atrium of the heart. The pulmonary veins carry oxygen-rich blood from the lungs to the heart.

Sponsors

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
CollaboratorUNKNOWN
Xinjiang Corps Hospital
CollaboratorUNKNOWN
China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Sign the informed consent form; 2. Clearly diagnosed as paroxysmal AF, willing to receive CPVI treatment; 3. A class I or class III antiarrhythmic drug with poor efficacy, or intolerance to drugs.

Exclusion criteria

1. Diagnosis of sinus rhythm at recruitment; 2. Age is \<18 years old or\> 75 years old; 3. Transthoracic echocardiography suggested a left atrial anterior and posterior diameter of\> 55mm; 4. Previous history of catheter ablation or surgical ablation for AF; 5. Left atrial thrombus recorded by ultrasound or CT; 6. With severe pulmonary diseases; 7. Previous history of cardiac surgery; 8. Patients with hyperthyroidism, atrial septal defect, mitral valve stenosis or severe coronary heart disease who need further treatment; 9. During pregnancy or lactation.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of AF at 1 year after surgery12 months after CPVIStandard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring
Autonomic nerve function assessment12 months after CPVIThe difference in DC values at 1 year compared to the preoperative baseline

Secondary

MeasureTime frameDescription
Recurrence of AF at 1 month after surgery1 months after CPVIStandard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring
Autonomic nerve function assessment1 months after CPVIThe difference in DC values at 1 month compared to the preoperative baseline
Recurrence of AF at 3 months after surgery3 months after CPVIStandard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring

Countries

China

Contacts

Primary Contactyan Yao, PhD
ianyao@263.net.cn13901121319
Backup Contactlihui Zheng, PhD
zhenglihui@263.net13910617612

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026