Trials / Completed
CompletedNCT05820035
A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia
Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia: A Prospective, Multicenter, Single-Arm Study in Mainland China
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 164 (actual)
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Paroxysmal Supraventricular Tachycardia
- Atrioventricular Nodal Reentrant Tachycardia
- Atrioventricular Reciprocating Tachycardia
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulsed 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 |
Timeline
- Start date
- 2023-03-09
- Primary completion
- 2024-02-23
- Completion
- 2024-12-09
- First posted
- 2023-04-19
- Last updated
- 2025-05-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05820035. Inclusion in this directory is not an endorsement.