Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

Paroxysmal Supraventricular Tachycardia Clinical Trial

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）

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05770921
• Other study ID #: 775035
• Status: Completed
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: July 13, 2023

Study information

• Verified date: December 2023
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 13, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Paroxysmal Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Supraventricular
• Tachycardia, Ventricular

Intervention

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

Locations

Country	Name	City	State
China	Ningbo First Hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Security Endpoints	Incidence of adverse events and serious adverse events associated with the study device	Within 6 months after sign the informed consent form
Primary	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
Primary	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	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
Secondary	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
Secondary	Evaluation of Force Sensing Pulsed Field Ablation Catheter	Evaluation of catheter operation performance;Catheter ablation parameters	1 Day of surgery
Secondary	Evaluation of Pulse Ablation equipment	System software operability; System operation stability; Hardware connection validity	immediately post ablation