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

Shanghai MicroPort EP MedTech Co., Ltd.1 site in 1 country10 target enrollmentJanuary 11, 2024

ConditionsPersistent Atrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Persistent Atrial Fibrillation
Sponsor: Shanghai MicroPort EP MedTech Co., Ltd.
Enrollment: 10
Locations: 1
Primary Endpoint: Immediate success rate
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 11, 2024

End Date

April 30, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai MicroPort EP MedTech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 18-75 years old;
•Documented symptomatic persistent atrial fibrillation, defined as persistent atrial fibrillation lasting more than 7 days and less than 1 year；
•Ineffective or intolerable after treatment with at least one Class I or Class III antiarrhythmic drug;
•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

•Patients who have undergone left atrial surgery
•Left atrial thrombosis
•Patients with combined atrial tachycardia and atypical atrial flutter
•Patients of childbearing age who are unable to use effective contraception during the 3-month period following enrollment
•Anterior and posterior left atrial diameter ≥ 55mm
•Left ventricular ejection fraction (LVEF) ≤ 40%
•Previous atrial septal repair or atrial mucinous tumor
•Active implants (e.g. pacemakers, ICDs, etc.) in the body
•NYHA class III-IV cardiac function
•Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)