Completed

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

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What is being tested

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

+ catheter ablation

Other
Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

From 18 to 75 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorShanghai MicroPort EP MedTech Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 11, 2024

Actual date on which the first participant was enrolled.

This clinical trial explores a new approach to treat patients who have persistent atrial fibrillation, a condition where the heart beats irregularly. The study aims to understand the effectiveness of using a combination of two types of procedures known as Radiofrequency Ablation (RFA) and Pulsed Field Ablation (PFA), guided by a high-tech system called the Columbus™ 3D EP Navigation System. This study is significant as it may offer new insights into better management of atrial fibrillation, potentially improving treatment outcomes for patients who have not responded well to traditional methods. Participants in the study will undergo catheter ablation using either a combination of PFA and RFA or just PFA alone. A catheter, which is a thin flexible tube, is used to deliver energy to the heart tissue to correct the irregular heartbeat. The study will monitor patients for any changes in their condition at 1 month and 3 months after the procedure. This monitoring helps in evaluating the success of the treatment and any potential side effects or risks associated with these advanced procedures.

Official TitleA Single-Center, Exploratory Clinical Study Combining Radiofrequency and Pulsed Field Ablation for Persistent Atrial Fibrillation Based on Columbus™ 3D EP Navigation System
NCT06232798
Principal SponsorShanghai MicroPort EP MedTech Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

4 inclusion criteria required to participate
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.
16 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

West China Hospital of Sichuan University

Chengdu, ChinaOpen West China Hospital of Sichuan University in Google Maps
CompletedOne Study Center