Trials / Completed
CompletedNCT05114954
Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
A Prospective, Multicenter, Single-arm Objective Performance Criteria Evaluation of the Safety and Efficacy of a Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical trial is to evaluate the safety and efficacy of a pulsed field ablation system developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd in the treatment of patients with paroxysmal atrial fibrillation
Detailed description
This study is a premarket clinical trial of a pulsed field ablation catheter system, this study evaluates the safety and effectiveness of the pulsed field ablation catheter system developed and produced by Hangzhou Dinova EP Technology Co., Ltd. in the endovascular interventional treatment of patients with paroxysmal atrial fibrillation, and provided a clinical basis for the formal application of this product in China.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CardioPulsesTM pulsed field ablation system | Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation. |
Timeline
- Start date
- 2021-10-27
- Primary completion
- 2022-06-30
- Completion
- 2023-03-30
- First posted
- 2021-11-10
- Last updated
- 2023-06-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05114954. Inclusion in this directory is not an endorsement.