Clinical trial NCT05820035: A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia
Official title: Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia: A Prospective, Multicenter, Single-Arm Study in Mainland China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Supraventricular Tachycardia
Atrioventricular Nodal Reentrant Tachycardia
Atrioventricular Reciprocating Tachycardia
Keywords: PFA
PSVT
AVNRT
AVRT
Lead sponsor: Shanghai MicroPort EP MedTech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter, single-arm study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary efficacy and safety endpoints
timeFrame: at end of the procedure, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Interim analysis
timeFrame: Refers to the postoperative phase after 6 months.
Other outcomes:
measure: Evaluation of Pulse Ablation equipment
timeFrame: immediately post ablation
measure: Evaluation of Ablation voltage
timeFrame: immediately post ablation
measure: Evaluation of Ablation sites
timeFrame: immediately post ablation
measure: Evaluation of Ablation x-ray time
timeFrame: immediately post ablation
Locations:
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University (original name :Ningbo First Hospital)
state: Zhejiang
Study officials:
References: