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

Persistent Atrial Fibrillation Clinical Trial

— PFA,RFA,PeAF  

Official title:

A Single-Center, Exploratory Clinical Study Combining Radiofrequency and Pulsed Field Ablation for Persistent Atrial Fibrillation Based on Columbus™ 3D EP Navigation System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232798
• Other study ID #: 775046
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: Shanghai MicroPort EP MedTech Co., Ltd.
• Contact: Rui Zeng
• Phone: 8618980606560
• Email: zengrui_0524[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Other:
• 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.
• catheter ablation
catheter ablation

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai MicroPort EP MedTech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate success rate	Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled.	1 Day of catheter ablation
Secondary	Ablation success at 3-month after the catheter ablation	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.	3 months