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Completed

NCT Number: NCT06232798

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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)
  • Those with acute or severe systemic infections
  • 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
  • Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders
  • Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment
  • Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Treatment and study plan

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

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

Other

catheter ablation

Other names: operation

Primary outcomes

  1. Immediate success rate

    Time frame: 1 Day of catheter ablation

    Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled.

Secondary outcomes

  1. Ablation success at 3-month after the catheter ablation

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort EP MedTech Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: PFA,RFA,PeAF

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 31, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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