A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia

Paroxysmal Supraventricular Tachycardia Clinical Trial

— PSVT  

Official title:

A Multicenter Clinical Study of Pulsed Electric Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter for the Treatment of Paroxysmal Supraventricular Tachycardia Under the Guidance of Columbus 3D EP Navigation System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05820035
• Other study ID #: 775044
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Shanghai MicroPort EP MedTech Co., Ltd.
• 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（PFA） Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia（PSVT）

Description:

The primary endpoint of this sutdy is the actue ablation success rate for all subjects, other endpoints include treatment success rate within 6 months after surgery, evaluation of equipment and cather. The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PFA ablation procedure) primary adverse events (AEs), ohter satety endpoints are incidence of AEs associated with the study devices and serious adverse events(SAEs).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18 years old = age = 80 years old, regardless of gender

2. Patients with symptomatic paroxysmal supraventricular tachycardia PSVT (AVNRT or AVRT) documented by ECG, Holter or electrophysiological examination

3. Recurrent episodes of disease prior to enrollment

4. Fully understand the treatment protocol and voluntarily sign an informed consent form, willing to undergo the tests, procedures and follow-ups required by the protocol

Exclusion Criteria:

1. Previous failure or recurrence of radiofrequency ablation

2. Left ventricular ejection fraction (LVEF) = 40%

3. Combined with atrial flutter or atrial fibrillation

4. Combination of thromboembolic disease

5. Women who are breastfeeding, pregnant or planning to become pregnant during the study period

6. Carrying active implants in the body (e.g., pacemakers, ICDs, etc.)

7. Patients with second-degree (type II) or third-degree atrioventricular block

8. NYHA Class III-IV cardiac function [Appendix 1]

9. Patients with congenital heart disease (excluding atrial septal defect and patent foramen ovale)

10. Patients with definite acute cerebrovascular disease (including cerebral hemorrhage, stroke, transient ischemic attack) within the last 1 month

11. cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)

12. Acute or severe systemic infection

13. Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases

14. Patients with significant bleeding tendency, hypercoagulable state and serious hematologic disorders

15. Patients who have participated or are participating in other clinical trials within 3 months before enrollment

16. Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

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
Shanghai MicroPort EP MedTech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	primary adverse events	The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PFA procedure) primary adverse events (AEs).	Refers to the postoperative phase within 7days postoperatively
Other	Incidence of adverse events and serious adverse events associated with the study device	Incidence of adverse events and serious adverse events associated with the study device	Refers to the postoperative phase 6 months postoperatively
Primary	acute 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 acute ablation success rate	15 minutes post ablation
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 3-Month Post-Procedure	Refers to the postoperative phase after 3 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 3 months postoperatively
Secondary	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	Evaluation of Force Sensing Pulsed Field Ablation Catheter	Evaluation of Surgery start time, Surgery end time, X-ray imaging time, Ablation voltage, Ablation modelm, Ablation sites ,Whether the catheter is in place well, Controllable degree of catheter bend adjustment, Stability of catheter positioning signals, Whether there is interference in the discharge of the conduit, et al.	immediately post ablation
Secondary	Evaluation of Pulse Ablation equipment	Whether the software can realize each set function, Whether the interface friendly and easy to operate, No abnormal software crash during the operation, et al.	immediately post ablation
Secondary	Interim analysis	To assess immediate ablation ablation success at 6 months postoperatively, by Holter.	Refers to the postoperative phase after 6 months.