A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia (PSVT)

Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia: A Prospective, Multicenter, Single-Arm Study in Mainland China

The purpose of this study was to explore the safety and efficacy of pulsed field ablation（PFA) in the treatment of paroxysmal pupraventricular pachycardia（PSVT）with a contact force(CF)-sensing PFA Catheter

Study Overview

• Status: Completed
• Conditions: Paroxysmal Supraventricular Tachycardia; Atrioventricular Nodal Reentrant Tachycardia; Atrioventricular Reciprocating Tachycardia
• Intervention / Treatment: Device: Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter

Detailed Description

The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs . The primary safety endpoints were to assess the incidences of serious adverse events (SAEs) at the end of the procedure , discharge and during the 6-month follow-up period.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • The First Affiliated Hospital of Ningbo University (original name :Ningbo First Hospital)

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. age from 18 to 80 years,
2. episode of PSVT recorded by a 12-lead surface electrocardiogram (ECG), 24-hour Holter monitoring, or esophageal electrophysiologic study (EES) before hospitalization
3. reproducible clinical tachycardia confirmed by the electrophysiological study (EPS).

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.

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: Experiment group; Patients of PSVT treated with PFA catheter.	Device: Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter; All subjects will be ablated using the pulsed field ablation device and CF-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
Primary efficacy and safety endpoints	The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs. The primary safety endpoints were to assess the incidences of SAEs at the end of the procedure and during the 6-month follow-up period.	at end of the procedure, 1-month follow-up, 3-month follow-up, 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interim analysis	To assess immediate ablation ablation success at 6 months postoperatively, by Holter in single center.	Refers to the postoperative phase after 6 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Evaluation of Ablation voltage	Record ablation voltage during ablation	immediately post ablation
Evaluation of Ablation sites	Record ablation sites during ablation	immediately post ablation
Evaluation of Ablation x-ray time	Record evaluation of Ablation x-ray time	immediately post ablation

Collaborators and Investigators

• Sponsor: Shanghai MicroPort EP MedTech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): December 9, 2024

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: PFA; PSVT; AVNRT; AVRT
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Tachycardia, Supraventricular; Tachycardia, Atrioventricular Nodal Reentry; Tachycardia, Reciprocating
• Other Study ID Numbers: 775044

Drug and device information, study documents

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