Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

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）

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Supraventricular Tachycardia
• Intervention / Treatment: Device: Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chu HuiMin; Phone Number: 0574-87085588; Email: markchu@126.com

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China
      • Ningbo First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

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
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

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): July 13, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 30, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: PFA; PSVT; AVNRT; AVRT
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular; Tachycardia, Supraventricular
• Other Study ID Numbers: 775035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No