A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia

N/ACompletedNCT05820035

Shanghai MicroPort EP MedTech Co., Ltd.164 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Paroxysmal Supraventricular Tachycardia Atrioventricular Nodal Reentrant Tachycardia Atrioventricular Reciprocating Tachycardia

Interventions

Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation CatheterDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Ningbo University (original name :Ningbo First Hospital)

Ningbo, Zhejiang, China

Outcomes

Primary Outcomes

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.

Time frame: at end of the procedure, 1-month follow-up, 3-month follow-up, 6-month follow-up

Secondary Outcomes

Interim analysis

To assess immediate ablation ablation success at 6 months postoperatively, by Holter in single center.

Time frame: Refers to the postoperative phase after 6 months.

Data from ClinicalTrials.gov

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