Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter

January 18, 2026 updated by: Beijing Anzhen Hospital

Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter: A Prospective Study on Effectiveness and Safety

This observational study aims to evaluate the effectiveness and safety of a circular-shaped pulsed field ablation (PFA) catheter for CTI ablation under the guidance of intracardiac echocardiography (ICE). The main question it aims to answer is:

Is the circular-shaped PFA catheter an effective and safe tool for achieving acute success for CTI ablation? Patients undergoing CTI ablation with a circular-shaped PFA catheter will be prospectively enrolled.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Song Zuo, Doctoral
  • Phone Number: +86-18801427775
  • Email: song_zuo@126.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All eligible patients scheduled for CTI ablation at Beijing Anzhen Hospital will be asked to participate in this study.

Description

Inclusion Criteria:

  • Paroxysmal or persistent atrial fibrillation
  • Aged 18 years or older
  • Scheduled for CTI ablation
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Previous CTI ablation
  • Significant congenital heart disease or structural anomaly affecting the CTI
  • Active intracardiac thrombus
  • Pregnancy or lactation
  • Severe renal/hepatic insufficiency
  • Active systemic infection or sepsis
  • Life expectancy of less than 12 months
  • Unable to provide written informed consent.

Study Plan

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

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Success of CTI Block
Time Frame: Within the ablation procedure
Bidirectional block was assessed immediately after the last ablation application and re-confirmed at the end of the 20-minute observation period.
Within the ablation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CTI Procedural Time
Time Frame: Within the ablation procedure
Within the ablation procedure
Total PF Application Time
Time Frame: Within the ablation procedure
Within the ablation procedure
Number of PFA Applications
Time Frame: Within the ablation procedure
Within the ablation procedure
Procedure-related Complications
Time Frame: Within 30 days after the ablation procedure
Including vascular complications, cardiac tamponade, thromboembolic events, conduction system injury, or other adverse events judged procedure-related.
Within 30 days after the ablation procedure
Freedom from Any Atrial Arrhythmia
Time Frame: 12 months
Arrhythmia recurrence is defined as any documented atrial tachyarrhythmia (atrial flutter, atrial fibrillation, or atrial tachycardia) lasting ≥30 seconds, confirmed by ECG or ambulatory monitoring.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

August 25, 2025

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFA-CTI ablation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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