Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia: A Prospective, Multicenter, Single-Arm Study in Mainland China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Primary efficacy and safety endpoints
- Status
- Completed
- Last Updated
- 11 months ago
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.
Investigators
Eligibility Criteria
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
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.)