Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Paroxysmal or persistent atrial fibrillation
Aged 18 years or older
Scheduled for CTI ablation
Able and willing to provide written informed consent
Disqualifiers
Previous CTI ablation
Significant congenital heart disease or structural anomaly affecting the CTI
Active intracardiac thrombus
Pregnancy or lactation
Trial population
All eligible patients scheduled for CTI ablation at Beijing Anzhen Hospital will be asked to participate in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ICE-guided CTI ablation with PFA
Procedure/SurgeryCavotricuspid isthmus ablation with a circular-shaped pulsed field ablation catheter guided by intracardiac echocardiography
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Acute Success of CTI Block
Bidirectional block was assessed immediately after the last ablation application and re-confirmed at the end of the 20-minute observation period.
Time frame
Within the ablation procedureSecondary outcomes
1
CTI Procedural Time
Time frame
Within the ablation procedure2
Total PF Application Time
Time frame
Within the ablation procedure3
Number of PFA Applications
Time frame
Within the ablation procedure4
Procedure-related Complications
Including vascular complications, cardiac tamponade, thromboembolic events, conduction system injury, or other adverse events judged procedure-related.
Time frame
Within 30 days after the ablation procedureSponsors and contacts
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Source ClinicalTrials.gov