RecruitingNCT07353775

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

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


Sponsor

Beijing Anzhen Hospital

Enrollment

150 participants

Start Date

Jan 15, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria8

  • 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.

Interventions

PROCEDUREICE-guided CTI ablation with PFA

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


Locations(1)

Beijing Anzhen Hospital

Beijing, China

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NCT07353775


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