The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
NCT Number: NCT07503769
The objective of this study is to evaluate the safety of the dual-energy ablation catheter manufactured by Shanghai MicroPort EP Medical Technology Co., Ltd. in the treatment of tachyarrhythmias.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Ningbo, Zhejiang, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter.
Other names: Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter
Time frame: at end of the procedure, 1-month follow-up, 3-month follow-up
The primary efficacy endpoints were to evaluate the acute and 3-month follow-up success rate after ablation
Time frame: immediate ablation
It is defined as the disappearance of the identical outflow tract ventricular arrhythmia that was present pre-ablation, with no inducible sustained identical outflow tract ventricular arrhythmia during 20 minutes of observation following pharmacological and/or electrophysiological stimulation.
Shanghai MicroPort EP MedTech Co., Ltd.
Industry
Contact-Force Guided Hybrid-Dual-Energy Ultra-Saline-Irrigated Ablation First-in-Man for Ventricular Arrhythmia: CHU VA
Acronym: CHU-VA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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