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

January 2, 2024 updated by: China National Center for Cardiovascular Diseases

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing CPVI due to paroxysmal atrial fibrillation.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of AF at 1 year after surgery
Time Frame: 12 months after CPVI
Standard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring
12 months after CPVI
Autonomic nerve function assessment
Time Frame: 12 months after CPVI
The difference in DC values at 1 year compared to the preoperative baseline
12 months after CPVI

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Collaborators

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Xinjiang Corps Hospital

Investigators

  • Study Chair: yan Yao, PhD, Fuwai Hospital,National Center for Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-RW320-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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