A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2024-12-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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Paroxysmal Supraventricular Tachycardia Atrioventricular Nodal Reentrant Tachycardia Atrioventricular Reciprocating Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, multicenter, single-arm study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experiment group

Patients of PSVT treated with PFA catheter.

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No