NCT05820035

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2024

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

March 17, 2023

Last Update Submit

May 23, 2025

Conditions

Paroxysmal Supraventricular TachycardiaAtrioventricular Nodal Reentrant TachycardiaAtrioventricular Reciprocating Tachycardia

Keywords

PFAPSVTAVNRTAVRT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Interim analysis

    Refers to the postoperative phase after 6 months.

Other Outcomes (4)

  • Evaluation of Pulse Ablation equipment

    immediately post ablation

  • Evaluation of Ablation voltage

    immediately post ablation

  • Evaluation of Ablation sites

    immediately post ablation

  • +1 more other outcomes

Study Arms (1)

Experiment group

EXPERIMENTAL

Patients of PSVT treated with PFA catheter.

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

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

Experiment group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ningbo, Zhejiang, 315000, China

Location

MeSH Terms

Conditions

Tachycardia, VentricularTachycardia, Atrioventricular Nodal Reentry

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsTachycardia, Reciprocating

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, multicenter, single-arm study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 19, 2023

Study Start

March 9, 2023

Primary Completion

February 23, 2024

Study Completion

December 9, 2024

Last Updated

May 28, 2025

Record last verified: 2025-05

Locations

CN(1)