Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

Not Applicable

Completed

• Conditions: Paroxysmal Supraventricular Tachycardia
• Interventions: Device: Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter

• Registration Number: NCT05770921
• Lead Sponsor: Ningbo No. 1 Hospital

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

Study Timeline

• Study Start: 2022-10-11
• Study First Submitted: 2023-01-30
• Primary Completion: 2023-02-01
• Study First Submitted QC: 2023-03-14
• Study First Posted: 2023-03-16
• Study Completion: 2023-07-13
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-30
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients with symptomatic paroxysmal supraventricular tachycardia including:Atrioventricular nodal re-entrant tachycardia, Atrioventricular arrhythmias;
2. Willingness to undergo an evaluation to validate the requirements of the protocol.
3. Voluntary signed informed consent and willingness to undergo the tests and procedures required by the protocol.

Exclusion Criteria

1. Patients with structural heart disease
2. History of any cardiac surgery
3. Failure of prior ablation of PSVT
4. Presence of any implantation, such as artificial valves, permanent pacemakers, etc
5. Patients with active systemic infections
6. Any condition contraindicating septal puncture or retrograde transaortic approach for procedures
7. Any condition contraindicating heparin or aspirin
8. Patients with advanced malignant tumor
9. Any woman known to be pregnant or breastfeeding
10. Unwilling or unable to comply fully with study procedures and follow-up
11. Unable to provide own informed consent
12. Coexistence with other arrhythmias

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-randomized	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

Primary Outcome Measures

Name	Time	Method
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
Rate of Treatment Success at 6-Month Post-Procedure	Refers to the postoperative phase after 6 months postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Force Sensing Pulsed Field Ablation Catheter	1 Day of surgery	Evaluation of catheter operation performance;Catheter ablation parameters
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.
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.
Evaluation of Pulse Ablation equipment	immediately post ablation	System software operability; System operation stability; Hardware connection validity

Trial Locations

Locations (1)

Ningbo First Hospital; 🇨🇳 Ningbo, Zhejiang, China