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

Atrial Fibrillation Recurrent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202209
• Other study ID #: 2022-RW320-11
• Status: Recruiting
• Start date: September 13, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: November 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: yan Yao, PhD
• Phone: 13901121319
• Email: ianyao[@]263.net.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Recurrent
• Recurrence

Intervention

Procedure:
• Circumferential Pulmonary Vein Isolation
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.

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Xinjiang Corps Hospital, Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (24)

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Hu F, Zheng L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Right anterior ganglionated plexus: The primary target of cardioneuroablation? Heart Rhythm. 2019 Oct;16(10):1545-1551. doi: 10.1016/j.hrthm.2019.07.018. Epub 2019 Jul 19. — View Citation

Hu F, Zheng L, Liu S, Shen L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Avoidance of Vagal Response During Circumferential Pulmonary Vein Isolation: Effect of Initiating Isolation From Right Anterior Ganglionated Plexi. Circ Arrhythm Electrophysiol. 20 — View Citation

Hu F, Zheng L, Liu S, Shen L, Liang E, Liu L, Wu L, Ding L, Yao Y. The impacts of the ganglionated plexus ablation sequence on the vagal response, heart rate, and blood pressure during cardioneuroablation. Auton Neurosci. 2021 Jul;233:102812. doi: 10.1016 — View Citation

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Ketels S, Houben R, Van Beeumen K, Tavernier R, Duytschaever M. Incidence, timing, and characteristics of acute changes in heart rate during ongoing circumferential pulmonary vein isolation. Europace. 2008 Dec;10(12):1406-14. doi: 10.1093/europace/eun287. — View Citation

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Sun W, Zheng L, Qiao Y, Shi R, Hou B, Wu L, Guo J, Zhang S, Yao Y. Catheter Ablation as a Treatment for Vasovagal Syncope: Long-Term Outcome of Endocardial Autonomic Modification of the Left Atrium. J Am Heart Assoc. 2016 Jul 8;5(7):e003471. doi: 10.1161/ — View Citation

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Tu B, Wu L, Hu F, Fan S, Liu S, Liu L, Ding L, Zheng L, Yao Y. Cardiac deceleration capacity as an indicator for cardioneuroablation in patients with refractory vasovagal syncope. Heart Rhythm. 2022 Apr;19(4):562-569. doi: 10.1016/j.hrthm.2021.12.007. Epu — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of AF at 1 year after surgery	Standard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring	12 months after CPVI
Primary	Autonomic nerve function assessment	The difference in DC values at 1 year compared to the preoperative baseline	12 months after CPVI
Secondary	Recurrence of AF at 1 month after surgery	Standard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring	1 months after CPVI
Secondary	Autonomic nerve function assessment	The difference in DC values at 1 month compared to the preoperative baseline	1 months after CPVI
Secondary	Recurrence of AF at 3 months after surgery	Standard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring	3 months after CPVI
Secondary	Autonomic nerve function assessment	The difference in DC values at 3 months compared to the preoperative baseline	3 months after CPVI