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NCT Number: NCT07353775

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

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ICE-guided CTI ablation with PFA

Procedure

Cavotricuspid isthmus ablation with a circular-shaped pulsed field ablation catheter guided by intracardiac echocardiography

Primary outcomes

  1. 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.

Secondary outcomes

  1. CTI Procedural Time

    Time frame: Within the ablation procedure

  2. Total PF Application Time

    Time frame: Within the ablation procedure

  3. Number of PFA Applications

    Time frame: Within the ablation procedure

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Song Zuo, Doctoral

CONTACT

[email protected]

+86-18801427775

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

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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