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

NCT07353775 — Recruiting, 150 participants, Beijing Anzhen Hospital

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

Registry	NCT07353775
Status	Recruiting
Study type	Observational
Enrollment	150 (Estimated)
Sponsor	Beijing Anzhen Hospital (Other)
Conditions	Atrial Fibrillation (AF), Atrial Flutter
Interventions	ICE-guided CTI ablation with PFA (Procedure)
Dates	start 2025-01-15, primary completion 2026-03-15 (estimated), completion 2026-03-15 (estimated), first posted 2026-01-20, last updated 2026-01-20
Locations	1 site in China

-Summary

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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+Arms and interventions

ICE-guided CTI ablation with PFA (Procedure): Cavotricuspid isthmus ablation with a circular-shaped pulsed field ablation catheter guided by intracardiac echocardiography

+Outcome measures

Primary outcomes

Acute Success of CTI Block [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

CTI Procedural Time [Within the ablation procedure]
Total PF Application Time [Within the ablation procedure]
Number of PFA Applications [Within the ablation procedure]
Procedure-related Complications [Within 30 days after the ablation procedure]: Including vascular complications, cardiac tamponade, thromboembolic events, conduction system injury, or other adverse events judged procedure-related.
Freedom from Any Atrial Arrhythmia [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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Beijing Anzhen Hospital	Beijing	China	Recruiting