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The purpose of this study was to explore the safety and efficacy of pulsed field ablation(PFA) in the treatment of paroxysmal pupraventricular pachycardia(PSVT)with a contact force(CF)-sensing PFA Catheter
The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs . The primary safety endpoints were to assess the incidences of serious adverse events (SAEs) at the end of the procedure , discharge and during the 6-month follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiment group | Experimental | Patients of PSVT treated with PFA catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter | Device | All subjects will be ablated using the pulsed field ablation device and CF-sensing pulsed field ablation catheter in the management of their paroxysmal supraventricular tachycardia |
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy and safety endpoints | The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs. The primary safety endpoints were to assess the incidences of SAEs at the end of the procedure and during the 6-month follow-up period. | at end of the procedure, 1-month follow-up, 3-month follow-up, 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Interim analysis | To assess immediate ablation ablation success at 6 months postoperatively, by Holter in single center. | Refers to the postoperative phase after 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Pulse Ablation equipment | Whether the software can realize each set function, Whether the interface friendly and easy to operate, No abnormal software crash during the operation, et al. | immediately post ablation |
| Evaluation of Ablation voltage |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Ningbo University (original name :Ningbo First Hospital) | Ningbo | Zhejiang | 315000 | China |
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Prospective, multicenter, single-arm study
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Record ablation voltage during ablation
| immediately post ablation |
| Evaluation of Ablation sites | Record ablation sites during ablation | immediately post ablation |
| Evaluation of Ablation x-ray time | Record evaluation of Ablation x-ray time | immediately post ablation |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D013611 | Tachycardia, Atrioventricular Nodal Reentry |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054139 | Tachycardia, Reciprocating |
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