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Completed

NCT Number: NCT05820035

A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia

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

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Key information

Conditions

Paroxysmal Supraventricular Tachycardia Arrhythmias, Cardiac AtrioVentricular Nodal Reentrant Tachycardia Atrioventricular Reciprocating Tachycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Atrioventricular Nodal Reentry Tachycardia, Reciprocating Tachycardia, Ventricular

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ningbo, Zhejiang, 315000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous failure or recurrence of radiofrequency ablation
  • Left ventricular ejection fraction (LVEF) ≤ 40%
  • Combined with atrial flutter or atrial fibrillation
  • Combination of thromboembolic disease
  • Women who are breastfeeding, pregnant or planning to become pregnant during the study period
  • Carrying active implants in the body (e.g., pacemakers, ICDs, etc.)
  • Patients with second-degree (type II) or third-degree atrioventricular block
  • NYHA Class III-IV cardiac function [Appendix 1]
  • Patients with congenital heart disease (excluding atrial septal defect and patent foramen ovale)
  • Patients with definite acute cerebrovascular disease (including cerebral hemorrhage, stroke, transient ischemic attack) within the last 1 month
  • 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)
  • Acute or severe systemic infection
  • Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases
  • Patients with significant bleeding tendency, hypercoagulable state and serious hematologic disorders
  • Patients who have participated or are participating in other clinical trials within 3 months before enrollment
  • Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Treatment and study plan

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

Device

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

Primary outcomes

  1. Primary efficacy and safety endpoints

    Time frame: 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 outcomes

  1. Interim analysis

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

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

Other outcomes

  1. Evaluation of Pulse Ablation equipment

    Time frame: 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.

  2. Evaluation of Ablation voltage

    Time frame: immediately post ablation

    Record ablation voltage during ablation

  3. Evaluation of Ablation sites

    Time frame: immediately post ablation

    Record ablation sites during ablation

  4. Evaluation of Ablation x-ray time

    Time frame: immediately post ablation

    Record evaluation of Ablation x-ray time

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort EP MedTech Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: PSVT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2023
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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