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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICE-guided CTI ablation with PFA | Procedure | Cavotricuspid isthmus ablation with a circular-shaped pulsed field ablation catheter guided by intracardiac echocardiography |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within the ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| CTI Procedural Time | Within the ablation procedure | |
| Total PF Application Time | Within the ablation procedure | |
| Number of PFA Applications |
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Inclusion Criteria:
Exclusion Criteria:
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All eligible patients scheduled for CTI ablation at Beijing Anzhen Hospital will be asked to participate in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Zuo, Doctoral | Contact | +86-18801427775 | song_zuo@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D051183 | Desmoglein 1 |
| ID | Term |
|---|---|
| D051182 | Desmogleins |
| D051181 | Desmosomal Cadherins |
| D015820 | Cadherins |
| D015815 | Cell Adhesion Molecules |
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| Within the ablation procedure |
| Procedure-related Complications | Including vascular complications, cardiac tamponade, thromboembolic events, conduction system injury, or other adverse events judged procedure-related. | Within 30 days after the ablation procedure |
| Freedom from Any Atrial Arrhythmia | 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. | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008562 |
| Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D001324 | Autoantigens |