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A Dual Energy Catheter (PFA and RFA) and a PFA Catheter for the Treatment of PeAF | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT06232798•Shanghai MicroPort EP MedTech Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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)
+6 more criteria

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

January 11, 2024

Primary Completion Date

September 10, 2024

Completion Date

April 30, 2025

Last Updated

May 21, 2025

Enrollment

ACTUAL participants

Conditions

Persistent Atrial Fibrillation

Interventions

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

OTHER

Medtronic Terminate AF Study

NCT03546374

Persistent Atrial FibrillationLongstanding Persistent Atrial Fibrillation

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RECRUITINGNA

FIH Study of PFLotus in Persistent Atrial Fibrillation

NCT07301190

Persistent Atrial Fibrillation

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RECRUITINGNA

Hybrid Ablation of Atrial Fibrillation in Heart Failure

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Medtronic Terminate AF Study

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