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

NCT ID: NCT06232798

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2025-04-30

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

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A prospective, singlecenter, single-arm clinical study

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

This study will be used two catheters, the contact force sensing catheter able to deliver both RF and PFA energy, this catheter provides both the radiofrequency (RF) energy and pulsed field ablation (PFA) energy to the catheter through the toggling of the two energy sources on the generator monitor. Another catheter is PFA catheter only.

catheter ablation

Intervention Type: OTHER

catheter ablation

Interventions

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

This study will be used two catheters, the contact force sensing catheter able to deliver both RF and PFA energy, this catheter provides both the radiofrequency (RF) energy and pulsed field ablation (PFA) energy to the catheter through the toggling of the two energy sources on the generator monitor. Another catheter is PFA catheter only.

Intervention Type: OTHER

catheter ablation

catheter ablation

Intervention Type: OTHER

Other Intervention Names

operation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort EP MedTech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

775046

Identifier Type: -

Identifier Source: org_study_id