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

Last updated: May 20, 2025
Sponsor: Shanghai MicroPort EP MedTech Co., Ltd.
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Dysrhythmia

Arrhythmia

Treatment

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

catheter ablation

Clinical Study ID

NCT06232798
775046
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18-75 years old;

  2. Documented symptomatic persistent atrial fibrillation, defined as persistent atrialfibrillation lasting more than 7 days and less than 1 year;

  3. Ineffective or intolerable after treatment with at least one Class I or Class IIIantiarrhythmic drug;

  4. Fully understand the treatment protocol and voluntarily sign the informed consentform and be willing to undergo the tests, procedures and follow-ups required by theprotocol.

Exclusion

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 duringthe 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 cerebralhemorrhage, stroke, transient ischemic attack)

  11. Cardiovascular events within the last 3 months (including acute myocardialinfarction, coronary intervention or heart bypass surgery, prosthetic valvereplacement 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 diseasethat, 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 severehematologic 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 forparticipation in this trial.

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter
Phase:
Study Start date:
January 11, 2024
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

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