Atrioventricular Nodal Reentrant Tachycardia, Atrioventricular Reciprocating Tachycardia, Paroxysmal Supraventricular Tachycardia
Conditions
Keywords
PFA, PSVT, AVNRT, AVRT
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.
Interventions
DEVICEPulsed 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
Sponsors
Shanghai MicroPort EP MedTech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicenter, single-arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary efficacy and safety endpoints | 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
| Measure | Time frame | Description |
|---|---|---|
| Interim analysis | Refers to the postoperative phase after 6 months. | To assess immediate ablation ablation success at 6 months postoperatively, by Holter in single center. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Pulse Ablation equipment | 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. |
| Evaluation of Ablation voltage | immediately post ablation | Record ablation voltage during ablation |
| Evaluation of Ablation sites | immediately post ablation | Record ablation sites during ablation |
| Evaluation of Ablation x-ray time | immediately post ablation | Record evaluation of Ablation x-ray time |
Countries
China
Outcome results
None listed