A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia

Study Overview
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Brief Summary
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The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation（PFA） Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia（PSVT）

Detailed Description
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The primary endpoint of this sutdy is the actue ablation success rate for all subjects, other endpoints include treatment success rate within 6 months after surgery, evaluation of equipment and cather. The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PFA ablation procedure) primary adverse events (AEs), ohter satety endpoints are incidence of AEs associated with the study devices and serious adverse events(SAEs).

Official Title
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A Multicenter Clinical Study of Pulsed Electric Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter for the Treatment of Paroxysmal Supraventricular Tachycardia Under the Guidance of Columbus 3D EP Navigation System

Conditions
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Paroxysmal Supraventricular Tachycardia

Intervention / Treatment
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* Device: Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old ≤ age ≤ 80 years old, regardless of gender Patients with symptomatic paroxysmal supraventricular tachycardia PSVT (AVNRT or AVRT) documented by ECG, Holter or electrophysiological examination Recurrent episodes of disease prior to enrollment Fully understand the treatment protocol and voluntarily sign an informed consent form, willing to undergo the tests, procedures and follow-ups required by the protocol Exclusion Criteria: Previous failure or recurrence of radiofrequency ablation Left ventricular ejection fraction (LVEF) ≤ 40% Combined with atrial flutter or atrial fibrillation Combination of thromboembolic disease Women who are breastfeeding, pregnant or planning to become pregnant during the study period Carrying active implants in the body (e.g., pacemakers, ICDs, etc.) Patients with second-degree (type II) or third-degree atrioventricular block NYHA Class III-IV cardiac function [Appendix 1] Patients with congenital heart disease (excluding atrial septal defect and patent foramen ovale) Patients with definite acute cerebrovascular disease (including cerebral hemorrhage, stroke, transient ischemic attack) within the last 1 month cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy) Acute or severe systemic infection Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases Patients with significant bleeding tendency, hypercoagulable state and serious hematologic disorders Patients who have participated or are participating in other clinical trials within 3 months before enrollment Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multicenter, single-group target value, interventional, non-inferiority study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experiment group<br>Patients treated with PFA catheter. | Device: Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute 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 acute ablation success rate | 15 minutes post ablation | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Rate of Treatment Success at 3-Month Post-Procedure | Refers to the postoperative phase after 3 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 3 months postoperatively | 
| 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 | 
| Evaluation of Force Sensing Pulsed Field Ablation Catheter | Evaluation of Surgery start time, Surgery end time, X-ray imaging time, Ablation voltage, Ablation modelm, Ablation sites ,Whether the catheter is in place well, Controllable degree of catheter bend adjustment, Stability of catheter positioning signals, Whether there is interference in the discharge of the conduit, et al. | immediately post ablation | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PFA, PSVT, AVNRT, AVRT