Clinical trial NCT06307860: Comparison of Different Ablation Surgeries on Left Atrial Reverse Remodeling in Patients With Atrial Fibrillation
Official title: Comparison of Pulse Field Ablation and Radiofrequency Ablation in Left Atrial Reverse Remodeling in Patients With Paroxysmal Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: Pulsed field ablation
radiofrequency ablation
atrial fibrillation
reconfiguration
Lead sponsor: The Affiliated Ganzhou Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion of paroxysmal atrial fibrillation patients who underwent ablation surgery at Ganzhou People's Hospital between June 2022 and June 2024 and met the inclusion criteria

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.

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.

Primary outcomes:
measure: Recurrence rate of atrial arrhythmias
timeFrame: Follow up for 6 months after surgery
measure: Left atrial end diastolic diameter
timeFrame: Follow up for 6 months after surgery
Secondary outcomes:
measure: p wave dispersion
timeFrame: Follow up for 6 months after surgery
measure: Pulmonary vein stenosis rate
timeFrame: Follow up for 6 months after surgery
Other outcomes:
measure: Postoperative complications
timeFrame: Complete surgery until 6 months after surgery
Locations:
city: Ganzhou
country: China
facility: Ganzhou People's Hospital
state: Jiangxi
Study officials:
affiliation: The Affiliated Ganzhou Hospital, Jiangxi Medical College, Nanchang University
name: Wan Yun, Bachelor
role: STUDY_DIRECTOR
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