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

July 7, 2024 updated by: Yun Wan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • Ganzhou People's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
P group
Perform pulsed field ablation surgery after meeting the inclusion criteria
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.
R group
Perform radiofrequency ablation surgery after meeting the inclusion criteria
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate of atrial arrhythmias
Time Frame: Follow up for 6 months after surgery
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
Time Frame: Follow up for 6 months after surgery
Follow up patient's left atrial diastolic diameter indicated by echocardiography and left atrial CTA
Follow up for 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
p wave dispersion
Time Frame: Follow up for 6 months after surgery
ECG measurement of P-wave dispersion
Follow up for 6 months after surgery
Pulmonary vein stenosis rate
Time Frame: Follow up for 6 months after surgery
Pulmonary vein CTA assessment of pulmonary vein stenosis
Follow up for 6 months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: Complete surgery until 6 months after surgery
Evaluate the occurrence of complications after completing ablation surgery
Complete surgery until 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yun Wan

Investigators

  • Study Director: Wan Yun, Bachelor, The Affiliated Ganzhou Hospital, Jiangxi Medical College, Nanchang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15270977512@163.com

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At present, complete data has not been obtained

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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