Clinical trial NCT06202209: The Impact of Autonomic Function on Atrial Fibrillation Recurrence After Pulmonary Vein Ablation
Official title: The Impact of Autonomic Function on Recurrence Following Circumferential Pulmonary Vein Ablation for Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation Recurrent
Keywords: Atrial Fibrillation Recurrent
Early recurrent atrial arrhythmia
Cardioneuroablation
Automatic function
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
name: Xinjiang Corps Hospital
First posted: 2024-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing CPVI due to paroxysmal atrial fibrillation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence of AF at 1 year after surgery
timeFrame: 12 months after CPVI
measure: Autonomic nerve function assessment
timeFrame: 12 months after CPVI
Secondary outcomes:
measure: Recurrence of AF at 1 month after surgery
timeFrame: 1 months after CPVI
measure: Autonomic nerve function assessment
timeFrame: 1 months after CPVI
measure: Recurrence of AF at 3 months after surgery
timeFrame: 3 months after CPVI
measure: Autonomic nerve function assessment
timeFrame: 3 months after CPVI
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Fuwai Hospital,National Center for Cardiovascular Diseases
name: yan Yao, PhD
role: STUDY_CHAIR
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