Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

Sponsor

Ningbo No. 1 Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05770921

Collaborator

(none)

Enrollment

Location

Arm

6.6

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Paroxysmal Supraventricular Tachycardia	Device: Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

prospective, single-center, single-groupprospective, single-center, single-group

Masking:

None (Open Label)

Primary Purpose:

Treatment

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）

Actual Study Start Date :

Oct 11, 2022

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-randomized 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 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

Arm

Intervention/Treatment

Experimental: Non-randomized

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

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

Outcome Measures

Primary Outcome Measures

Immediate ablation success rate [15 minutes post ablation]
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

Secondary Outcome Measures

Rate of Treatment Success at 1-Month Post-Procedure [Refers to the postoperative phase after 1 months postoperatively]
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.
Rate of Treatment Success at 2-Month Post-Procedure [Refers to the postoperative phase after 2 months postoperatively]
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.
Evaluation of Force Sensing Pulsed Field Ablation Catheter [1 Day of surgery]
Evaluation of catheter operation performance;Catheter ablation parameters
Evaluation of Pulse Ablation equipment [immediately post ablation]
System software operability; System operation stability; Hardware connection validity

Other Outcome Measures

Security Endpoints [Within 2 months after sign the informed consent form]
Incidence of adverse events and serious adverse events associated with the study device

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Unwilling or unable to comply fully with study procedures and follow-up 9. Unable to provide own informed consent