ICE-guided cavotricuspid isthmus ablation with a circular pulsed-field catheter
Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter: A Prospective Study on Effectiveness and Safety
Beijing Anzhen Hospital · NCT07353775
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Anzhen Hospital (other) |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07353775 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing
- Beijing Anzhen Hospital — Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Song Zuo, Doctoral
- Email: song_zuo@126.com
- Phone: +86-18801427775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Atrial Flutter