Trials / Completed
CompletedNCT06232798
A Dual Energy Catheter (PFA and RFA) and a PFA Catheter for the Treatment of PeAF
A Single-Center, Exploratory Clinical Study Combining Radiofrequency and Pulsed Field Ablation for Persistent Atrial Fibrillation Based on Columbus™ 3D EP Navigation System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to treatment of patients with persistent atrial fibrillation with PFA/RFA. 10 patients will be treated by PFA/RFA catheter or PFA catheter only. Participants will followed 1、3 month after catheter ablation
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter | This study will be used two catheters, the contact force sensing catheter able to deliver both RF and PFA energy, this catheter provides both the radiofrequency (RF) energy and pulsed field ablation (PFA) energy to the catheter through the toggling of the two energy sources on the generator monitor. Another catheter is PFA catheter only. |
| OTHER | catheter ablation | catheter ablation |
Timeline
- Start date
- 2024-01-11
- Primary completion
- 2024-09-10
- Completion
- 2025-04-30
- First posted
- 2024-01-31
- Last updated
- 2025-05-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06232798. Inclusion in this directory is not an endorsement.