Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICE-guided CTI ablation with PFA.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Atrial Flutter. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter: A Prospective Study on Effectiveness and Safety
Overview
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.
Interventions
- Procedure ICE-guided CTI ablation with PFA
Cavotricuspid isthmus ablation with a circular-shaped pulsed field ablation catheter guided by intracardiac echocardiography
Primary outcome measures
- Acute Success of CTI Block [Time frame: Within the ablation procedure]
Secondary outcome measures (5)
- CTI Procedural Time [Time frame: Within the ablation procedure]
- Total PF Application Time [Time frame: Within the ablation procedure]
- Number of PFA Applications [Time frame: Within the ablation procedure]
- Procedure-related Complications [Time frame: Within 30 days after the ablation procedure]
- Freedom from Any Atrial Arrhythmia [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Anzhen Hospital — Beijing
Identifiers
NCT: NCT07353775 · PFA-CTI ablation