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Clinical Trials/NCT07353775
NCT07353775RecruitingNot Applicable

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

Beijing Anzhen Hospital0 sites150 target enrollmentStarted: January 15, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
150
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Investigators

Sponsor
Beijing Anzhen Hospital
Sponsor Class
Other
Responsible Party
Sponsor

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