A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia

Not Applicable

Completed

• Conditions: Paroxysmal Supraventricular Tachycardia; Atrioventricular Nodal Reentrant Tachycardia; Atrioventricular Reciprocating Tachycardia

• Registration Number: NCT05820035
• Lead Sponsor: Shanghai MicroPort EP MedTech Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2023-03-09
• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-19
• Primary Completion: 2024-02-23
• Study Completion: 2024-12-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary efficacy and safety endpoints	at end of the procedure, 1-month follow-up, 3-month follow-up, 6-month follow-up	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Ningbo University (original name :Ningbo First Hospital); 🇨🇳 Ningbo, Zhejiang, China