Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

• Sponsor: Shanghai MicroPort EP MedTech Co., Ltd. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05820035
• Collaborator: (none)
• Enrollment: 151
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.7
• Patients Per Site Per Month: 12.9

Study Details

Study Description

Brief 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）

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 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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 151 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, multicenter, single-group target value, interventional, non-inferiority studyProspective, multicenter, single-group target value, interventional, non-inferiority study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 9, 2023
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experiment group Patients treated with PFA catheter.	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

1. acute 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 acute ablation success rate

Secondary Outcome Measures

1. 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.

2. Rate of Treatment Success at 3-Month Post-Procedure [Refers to the postoperative phase after 3 months postoperatively]

   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.

3. 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.

4. Evaluation of Force Sensing Pulsed Field Ablation Catheter [immediately post ablation]

   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.

5. Evaluation of Pulse Ablation equipment [immediately post ablation]

   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.

Other Outcome Measures

1. primary adverse events [Refers to the postoperative phase within 7days postoperatively]

   The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PFA procedure) primary adverse events (AEs).

2. Incidence of adverse events and serious adverse events associated with the study device [Refers to the postoperative phase 6 months postoperatively]

   Incidence of adverse events and serious adverse events associated with the study device

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ningbo First Hospital	Ningbo	Zhejiang	China	315000

Sponsors and Collaborators

• Shanghai MicroPort EP MedTech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai MicroPort EP MedTech Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05820035
• Other Study ID Numbers: 775044
• First Posted: Apr 19, 2023
• Last Update Posted: Apr 19, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai MicroPort EP MedTech Co., Ltd.: PFA; PSVT; AVNRT; AVRT
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Supraventricular; Tachycardia, Ventricular

Study Results

No Results Posted as of Apr 19, 2023