A Dual Energy Catheter (PFA and RFA) and a PFA Catheter for the Treatment of PeAF

Not Applicable

Completed

• Conditions: Persistent Atrial Fibrillation
• Interventions: Other: a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter; Other: catheter ablation

• Registration Number: NCT06232798
• Lead Sponsor: Shanghai MicroPort EP MedTech Co., Ltd.

Brief Summary

The goal of this clinical trial is to treatment of patients with persistent atrial fibrillation with PFA/RFA. 10 patients will be treated by PFA/RFA catheter or PFA catheter only.

Participants will followed 1、3 month after catheter ablation

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-11
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-01-31
• Primary Completion: 2024-09-10
• Study Completion: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Aged 18-75 years old;
2. Documented symptomatic persistent atrial fibrillation, defined as persistent atrial fibrillation lasting more than 7 days and less than 1 year；
3. Ineffective or intolerable after treatment with at least one Class I or Class III antiarrhythmic drug;
4. Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol.

Exclusion Criteria

1. Patients who have undergone left atrial surgery
2. Left atrial thrombosis
3. Patients with combined atrial tachycardia and atypical atrial flutter
4. Patients of childbearing age who are unable to use effective contraception during the 3-month period following enrollment
5. Anterior and posterior left atrial diameter ≥ 55mm
6. Left ventricular ejection fraction (LVEF) ≤ 40%
7. Previous atrial septal repair or atrial mucinous tumor
8. Active implants (e.g. pacemakers, ICDs, etc.) in the body
9. NYHA class III-IV cardiac function
10. Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)
11. Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)
12. Those with acute or severe systemic infections
13. Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial
14. Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders
15. Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment
16. Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A prospective, singlecenter, single-arm clinical study	catheter ablation	-
A prospective, singlecenter, single-arm clinical study	a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter	-

Primary Outcome Measures

Name	Time	Method
Immediate success rate	1 Day of catheter ablation	Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled.

Secondary Outcome Measures

Name	Time	Method
Ablation success at 3-month after the catheter ablation	3 months	Ablation success is defined as no recurrence with no anti-arrhythmic drugs by taking history of symptoms from the patient and by Holter 24 Hours.

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China