ICE-guided cavotricuspid isthmus ablation with a circular pulsed-field catheter
Official title: Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter: A Prospective Study on Effectiveness and Safety
Run by Beijing Anzhen Hospital · NCT07353775 · Data updated 2026-11-12
This will see if a circular-shaped pulsed field ablation catheter, guided by intracardiac echocardiography, can safely and effectively achieve acute cavotricuspid isthmus ablation in adults with atrial fibrillation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Beijing Anzhen Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | January 15, 2025 |
| Main results expected | March 15, 2026 |
| Study ends | March 15, 2026 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT07353775 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with paroxysmal or persistent atrial fibrillation who are scheduled for CTI ablation and can provide informed consent are the ideal candidates.
✕Probably not a fit
Patients with prior CTI ablation, significant congenital or structural CTI anomalies, active intracardiac thrombus, pregnancy or lactation, severe renal/hepatic failure, active systemic infection, or life expectancy under 12 months are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational enrollment of adults undergoing cavotricuspid isthmus (CTI) ablation using a circular-shaped pulsed field ablation (PFA) catheter under intracardiac echocardiography (ICE) guidance. The main outcomes are acute procedural success (such as bidirectional CTI block) and peri-procedural safety, including procedural complications. Eligible participants are adults with paroxysmal or persistent atrial fibrillation scheduled for CTI ablation, with exclusions for prior CTI ablation, intracardiac thrombus, significant structural anomalies, severe organ failure, active infection, pregnancy, or limited life expectancy. The single-center protocol at Beijing Anzhen Hospital uses ICE to optimize catheter positioning and minimize collateral injury while collecting safety and effectiveness data.
Why it matters
Potential benefit: If successful, this approach could offer faster, more tissue-selective CTI ablation with reduced thermal injury and fewer complications compared with conventional techniques.
How similar studies have gone: Pulsed field ablation has shown promising safety and efficacy for pulmonary vein isolation, but its specific use for CTI ablation is less studied and remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Beijing Anzhen Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Song Zuo, Doctoral
- Email: song_zuo@126.com
- Phone: +86-18801427775
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.