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

N

National Center for Cardiovascular Diseases

Status

Enrolling

Conditions

Atrial Fibrillation Recurrent

Treatments

Procedure: Circumferential Pulmonary Vein Isolation

Study type

Observational

Funder types

Other

Identifiers

NCT06202209
2022-RW320-11

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

lihui Zheng, PhD; yan Yao, PhD

Data sourced from clinicaltrials.gov

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