Comparing two types of ablation surgeries for atrial fibrillation
Comparison of Pulse Field Ablation and Radiofrequency Ablation in Left Atrial Reverse Remodeling in Patients With Paroxysmal Atrial Fibrillation
This study is testing whether pulsed field ablation or radiofrequency ablation works better for people with paroxysmal atrial fibrillation by looking at their recovery and heart health after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Affiliated Ganzhou Hospital of Nanchang University Academic / other |
| Locations | 1 site (Ganzhou, Jiangxi) |
| Trial ID | NCT06307860 on ClinicalTrials.gov |
What this trial studies
This ambispective cohort study aims to compare the effects of pulsed field ablation and radiofrequency ablation in patients with paroxysmal atrial fibrillation. Patients will be divided into two groups based on the type of ablation they receive and will undergo a 6-month follow-up after surgery. The study will collect and analyze various data points, including surgical outcomes, postoperative complications, and recurrence rates of atrial arrhythmias. The goal is to evaluate which ablation method leads to better left atrial reverse remodeling and overall patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 diagnosed with paroxysmal atrial fibrillation who are willing to undergo catheter ablation.
Not a fit: Patients with significant left atrial enlargement or low left ventricular ejection fraction, as well as those with prior ablation surgeries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the more effective ablation technique for treating atrial fibrillation, potentially improving patient outcomes.
How similar studies have performed: While there have been studies on ablation techniques, this specific comparison of pulsed field ablation versus radiofrequency ablation in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ganzhou, Jiangxi
- Ganzhou People's Hospital — Ganzhou, Jiangxi, China (Recruiting)
Study contacts
- Study coordinator: Luo Jun, Doctor
- Email: luojun1966@163.com
- Phone: 13970107015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.