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

NCT06307860 | Recruiting FDA Device

• 1 other identifier: 15270977512@163.com
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Pulsed field ablation; radiofrequency ablation; atrial fibrillation; reconfiguration

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• p wave dispersion

  Follow up for 6 months after surgery

• Pulmonary vein stenosis rate

  Follow up for 6 months after surgery

Other Outcomes (1)

• Postoperative complications

  Complete surgery until 6 months after surgery

Study Arms (2)

P group

Perform pulsed field ablation surgery after meeting the inclusion criteria

Device: pulsed field ablation

R group

Perform radiofrequency ablation surgery after meeting the inclusion criteria

Procedure: radiofrequency ablation

Interventions

pulsed field ablation 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.

P group

radiofrequency ablation 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.

R group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yun Wan: lead

Study Sites (1)

Ganzhou People's Hospital

Ganzhou, Jiangxi, 341000, China

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Wan Yun, Bachelor

  The Affiliated Ganzhou Hospital, Jiangxi Medical College, Nanchang University

  STUDY DIRECTOR

Central Study Contacts

Luo Jun, Doctor

CONTACT

13970107015; luojun1966@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: June 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: March 1, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-03

Locations

CN (1)