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The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia.
The Primary Endpoint for efficacy is the number of subjects where ablation of each PSVT resulted in confirmation of electrical isolation of the PSVT 15 minutes following the last index PFA application with the investigational device
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-randomized | Experimental | All subjects will be ablated using the Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the management of their Paroxysmal Supraventricular Tachycardia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter | Device | All subjects will be ablated using the Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the management of their Paroxysmal Supraventricular Tachycardia |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate ablation success rate | The Primary Endpoint for efficacy is the number of subjects where ablation of each PSVT resulted in confirmation of electrical isolation of the PSVT 15 minutes following by catheter mapping and ECG to determine immediate ablation success rate | 15 minutes post ablation |
| Rate of Treatment Success at 6-Month Post-Procedure | Refers to the postoperative phase after 6 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number. | Refers to the postoperative phase after 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Treatment Success at 1-Month Post-Procedure | Refers to the postoperative phase after 1 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number. | Refers to the postoperative phase after 1 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Security Endpoints | Incidence of adverse events and serious adverse events associated with the study device | Within 6 months after sign the informed consent form |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo First Hospital | Ningbo | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38242530 | Derived | Shen C, Du X, Dai J, Feng M, Yu Y, Liu J, Fu G, Wang B, Jiang Y, Jin H, Chu H. Outcomes of Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia. Can J Cardiol. 2024 Jul;40(7):1294-1303. doi: 10.1016/j.cjca.2023.12.037. Epub 2024 Jan 17. |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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prospective, single-center, single-group
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| Rate of Treatment Success at 2-Month Post-Procedure | Refers to the postoperative phase after 2 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number. | Refers to the postoperative phase after 2 months postoperatively |
| Evaluation of Force Sensing Pulsed Field Ablation Catheter | Evaluation of catheter operation performance;Catheter ablation parameters | 1 Day of surgery |
| Evaluation of Pulse Ablation equipment | System software operability; System operation stability; Hardware connection validity | immediately post ablation |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |