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

Atrial Fibrillation Clinical Trial

Official title:

Comparison of Pulse Field Ablation and Radiofrequency Ablation in Left Atrial Reverse Remodeling in Patients With Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307860
• Other study ID #: 15270977512@163.com
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: The Affiliated Ganzhou Hospital of Nanchang University
• Contact: Luo Jun, Doctor
• Phone: 13970107015
• Email: luojun1966[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 1, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
China	Ganzhou People's Hospital	Ganzhou	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Yun Wan

Country where clinical trial is conducted

China, 

References & Publications (21)

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Schipper JH, Steven D, Luker J, Wormann J, van den Bruck JH, Filipovic K, Dittrich S, Scheurlen C, Erlhofer S, Pavel F, Sultan A. Comparison of pulsed field ablation and cryoballoon ablation for pulmonary vein isolation. J Cardiovasc Electrophysiol. 2023 — View Citation

Soulat-Dufour L, Lang S, Addetia K, Ederhy S, Adavane-Scheuble S, Chauvet-Droit M, Jean ML, Nhan P, Ben Said R, Kamami I, Issaurat P, Capderou E, Arnaud C, Boccara F, Lang RM, Cohen A. Restoring Sinus Rhythm Reverses Cardiac Remodeling and Reduces Valvula — View Citation

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Turagam MK, Musikantow D, Whang W, Koruth JS, Miller MA, Langan MN, Sofi A, Choudry S, Dukkipati SR, Reddy VY. Assessment of Catheter Ablation or Antiarrhythmic Drugs for First-line Therapy of Atrial Fibrillation: A Meta-analysis of Randomized Clinical Tr — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative complications	Evaluate the occurrence of complications after completing ablation surgery	Complete surgery until 6 months after surgery
Primary	Recurrence rate of atrial arrhythmias	Follow up patients for any recurrent symptoms and recheck electrocardiograms for atrial arrhythmias	Follow up for 6 months after surgery
Primary	Left atrial end diastolic diameter	Follow up patient's left atrial diastolic diameter indicated by echocardiography and left atrial CTA	Follow up for 6 months after surgery
Secondary	p wave dispersion	ECG measurement of P-wave dispersion	Follow up for 6 months after surgery
Secondary	Pulmonary vein stenosis rate	Pulmonary vein CTA assessment of pulmonary vein stenosis	Follow up for 6 months after surgery