Atrial Fibrillation (AF), Atrial Flutter
Conditions
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.
Interventions
PROCEDUREICE-guided CTI ablation with PFA
Cavotricuspid isthmus ablation with a circular-shaped pulsed field ablation catheter guided by intracardiac echocardiography
Sponsors
Beijing Anzhen Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Success of CTI Block | Within the ablation procedure | Bidirectional block was assessed immediately after the last ablation application and re-confirmed at the end of the 20-minute observation period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-related Complications | Within 30 days after the ablation procedure | Including vascular complications, cardiac tamponade, thromboembolic events, conduction system injury, or other adverse events judged procedure-related. |
| CTI Procedural Time | Within the ablation procedure | — |
| Total PF Application Time | Within the ablation procedure | — |
| Number of PFA Applications | Within the ablation procedure | — |
| Freedom from Any Atrial Arrhythmia | 12 months | Arrhythmia recurrence is defined as any documented atrial tachyarrhythmia (atrial flutter, atrial fibrillation, or atrial tachycardia) lasting ≥30 seconds, confirmed by ECG or ambulatory monitoring. |
Countries
China
Contacts
CONTACTSong Zuo, Doctoral
Outcome results
None listed