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

NCT06202209 | Unknown

• 1 other identifier: 2022-RW320-11
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation Recurrent

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Recurrence of AF at 1 year after surgery

  Standard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring

  12 months after CPVI

• Autonomic nerve function assessment

  The difference in DC values at 1 year compared to the preoperative baseline

  12 months after CPVI

Secondary Outcomes (4)

• Recurrence of AF at 1 month after surgery

  1 months after CPVI

• Autonomic nerve function assessment

  1 months after CPVI

• Recurrence of AF at 3 months after surgery

  3 months after CPVI

• Autonomic nerve function assessment

  3 months after CPVI

Interventions

Circumferential Pulmonary Vein Isolation PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing CPVI due to paroxysmal atrial fibrillation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine: collaborator
• Xinjiang Corps Hospital: collaborator

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

Related Publications (24)

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Study Officials

• yan Yao, PhD

  Fuwai Hospital,National Center for Cardiovascular Diseases

  STUDY CHAIR

Central Study Contacts

yan Yao, PhD

CONTACT

13901121319; ianyao@263.net.cn

lihui Zheng, PhD

CONTACT

13910617612; zhenglihui@263.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: September 13, 2023
• Primary Completion: June 30, 2024
• Study Completion: October 30, 2024
• Last Updated: January 11, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)