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

MicroPort

Status: Completed

Conditions: Persistent Atrial Fibrillation

Treatments: Other: catheter ablation; Other: a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT06232798

775046

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

A prospective, singlecenter, single-arm clinical study

Experimental group

Treatment:

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