CompletedNot Applicable

A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia

China164 participantsStarted 2023-03-09

Plain-language 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

Who can participate

Age range18 Years – 80 Years

SexALL

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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 \[Appendix 1\]

What they're measuring

Primary efficacy and safety endpoints

Timeframe: at end of the procedure, 1-month follow-up, 3-month follow-up, 6-month follow-up

Trial details

NCT IDNCT05820035

SponsorShanghai MicroPort EP MedTech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-23

View on ClinicalTrials.gov More Paroxysmal Supraventricular Tachycardia trials