Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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

Official Title
-----------------
An Exploratory Study of Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter Guided by Columbus 3D EP Navigation System in the Ablation Treatment of Paroxysmal Supraventricular Tachycardia（PSVT）

Conditions
-----------------
Paroxysmal Supraventricular Tachycardia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic paroxysmal supraventricular tachycardia including:Atrioventricular nodal re-entrant tachycardia, Atrioventricular arrhythmias; Willingness to undergo an evaluation to validate the requirements of the protocol. Voluntary signed informed consent and willingness to undergo the tests and procedures required by the protocol. Exclusion Criteria: Patients with intracardiac thrombosis at the time of study or with a history of thromboembolic event within past 3 months History of any cardiac surgery Presence of any implantation, such as artificial valves, permanent pacemakers, etc Patients with active systemic infections Any condition contraindicating septal puncture or retrograde transaortic approach for procedures Any condition contraindicating heparin or indobufen Patients with advanced malignant tumor Any woman known to be pregnant or breastfeeding 8. Unwilling or unable to comply fully with study procedures and follow-up 9. Unable to provide own informed consent
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, single-center, single-group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-randomized<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 | 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?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

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 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 | 

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