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The objective of this study is to evaluate the safety of the dual-energy ablation catheter manufactured by Shanghai MicroPort EP Medical Technology Co., Ltd. in the treatment of tachyarrhythmias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter ablation | Experimental | All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ablation | Device | All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of catheter ablation | The primary efficacy endpoints were to evaluate the acute and 3-month follow-up success rate after ablation | at end of the procedure, 1-month follow-up, 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate success rate of ablation | It is defined as the disappearance of the identical outflow tract ventricular arrhythmia that was present pre-ablation, with no inducible sustained identical outflow tract ventricular arrhythmia during 20 minutes of observation following pharmacological and/or electrophysiological stimulation. | immediate ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | China |
This trial protocol is available in Chinese only and has not yet been translated into English.
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| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |