Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia: A Prospective, Multicenter, Single-Arm Study in Mainland China
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Primary efficacy and safety endpoints
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Experiment group
Patients of PSVT treated with PFA catheter.
Intervention: Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter (Device)
Outcomes
Primary Outcomes
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
- Interim analysis(Refers to the postoperative phase after 6 months.)