Trials / Completed
CompletedNCT07452211
First in Man Study of Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 1 Patient
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is the first in man study of CadioPulseTM ( pulsed field ablation system) developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can be used for Pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation. This study aims to initially verify the safety and efficacy of the device.
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
- 2020-12-18
- Primary completion
- 2022-04-10
- Completion
- 2022-04-10
- First posted
- 2026-03-05
- Last updated
- 2026-03-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07452211. Inclusion in this directory is not an endorsement.