Comparison of Different Ablation Surgeries on Left Atrial Reverse Remodeling in Patients With Atrial Fibrillation

NCT ID: NCT06307860

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-03-01

Brief Summary

The goal of this Ambispective cohort Study is to compare in patients with paroxysmal atrial fibrillation undergo pulse field ablation and radiofrequency ablation, respectively. The main question it aims to answer are:Comparison of the therapeutic effects of pulse field ablation and traditional thermal ablation on patients with paroxysmal atrial fibrillation and postoperative left atrial reverse remodeling.Participants will Perform pulse field ablation or radiofrequency ablation according to different groups, and cooperate to complete outpatient follow-up 6 months after surgery.

Detailed Description

Patients with paroxysmal atrial fibrillation who underwent ablation surgery at Ganzhou People's Hospital from June 2022 to June 2024 were divided into two groups: pulse ablation group (P group) and radiofrequency ablation group (R group). Collect baseline data, preoperative and postoperative heart rate, white blood cell count, neutrophil to lymphocyte ratio, and uric acid, evaluate and record surgical data and postoperative complications for both groups, and follow up for 6 months after discharge. Collect and analyze the recurrence rate of atrial arrhythmias, electrocardiogram, echocardiography, and left atrial CTA of patients. Compare surgical data, postoperative complications, atrial structure and function, P-wave dispersion, and pulmonary vein stenosis between two groups.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

P group

Perform pulsed field ablation surgery after meeting the inclusion criteria

pulsed field ablation

Intervention Type: DEVICE

Selected patients were selected to undergo relevant surgeries, and their preoperative and postoperative baseline data were collected. They were followed up for 6 months after surgery.

R group

Perform radiofrequency ablation surgery after meeting the inclusion criteria

radiofrequency ablation

Intervention Type: PROCEDURE

Selected patients were selected to undergo relevant surgeries, and their preoperative and postoperative baseline data were collected. They were followed up for 6 months after surgery.

Interventions

pulsed field ablation

Selected patients were selected to undergo relevant surgeries, and their preoperative and postoperative baseline data were collected. They were followed up for 6 months after surgery.

Intervention Type: DEVICE

radiofrequency ablation

Selected patients were selected to undergo relevant surgeries, and their preoperative and postoperative baseline data were collected. They were followed up for 6 months after surgery.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1.Aged between 18-75 years old; 2.Patients confirmed by electrocardiogram or clinically diagnosed with atrial fibrillation; 3.Atrial fibrillation that terminates spontaneously or through intervention within 7 days after onset; 4.Accompanied by symptoms of atrial fibrillation; 5.The patient has a willingness to undergo catheter ablation treatment; 6.The patient agrees to be enrolled and has high compliance. They voluntarily participate in the trial, sign an informed consent form, and cooperate with the follow-up of this project.

Exclusion Criteria

• 1.The echocardiography shows that the anterior posterior diameter of the left atrium is ≥ 50mm, and the LVEF is ≤ 40%; 2.Esophageal echocardiography or CT examination suggests thrombus in the left atrium/left atrial appendage; 3.Preoperative confirmation of typical atrial flutter or other supraventricular tachycardia by electrocardiogram or Holter; 4.Previously underwent catheter ablation or other surgeries due to atrial fibrillation; 5.Previously underwent left atrial appendage closure surgery or left atrial appendage closure surgery, or planned to undergo one-stop left atrial appendage closure surgery; 6.Previously underwent valve repair or valve replacement surgery; 7.Implantable metal cardiac instruments that have implanted pacemakers, implantable cardioverters, defibrillators, or other devices that may interfere with the energy field of pulsed electric field ablation; 8.New York Heart Function Classification (NYHA) Level III or IV; 9.Cardiovascular events within 3 months prior to surgery (including acute myocardial infarction, coronary intervention or bypass surgery, atrial or ventricular incision); 10.Has undergone any carotid stent implantation or endarterectomy within 6 months prior to surgery; 11.Thromboembolic events (including transient ischemic attacks) occurring within 6 months prior to surgery; 12.Existence of wall thrombus, atrial septal occluder or patch, tumor, myxoma, or other abnormal conditions that hinder vascular puncture or catheter operation; 13.Severe lung disease (such as restrictive lung disease, constrictive or chronic obstructive pulmonary disease) or any other lung or respiratory system disease or dysfunction that can cause severe chronic symptoms; 14.Atrial fibrillation secondary to electrolyte disorders, thyroid diseases, or other reversible causes; 15.Known pulmonary vein stenosis; 16;Systemic active infection; 17.Severe organic heart disease; 18.Contraindications to anticoagulant therapy, X-rays, and severe hematological disorders; 19.Expected life<12 months; 20.Pregnancy test positive for women of childbearing age or in lactation or planning to conceive within the next 12 months; 21.Patients who are participating in clinical trials of other experimental biological agents, drugs, or devices and have not completed them; 22.Other researchers believe that it is not appropriate to participate in this experiment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yun Wan

OTHER

Sponsor Role: lead

Responsible Party

Yun Wan

resident doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wan Yun, Bachelor

Role: STUDY_DIRECTOR

The Affiliated Ganzhou Hospital, Jiangxi Medical College, Nanchang University

Locations

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Luo Jun, Doctor

Role: CONTACT

luojun1966@163.com

13970107015

Facility Contacts

Wan Yun, Bachelor

Role: primary

15270977512@163.com

15270977512

Luo Jun, doctor

Role: backup

luojun1966@163.com

13970107015

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Other Identifiers

15270977512@163.com

Identifier Type: -

Identifier Source: org_study_id