Fuwai Yunnan Hospital
Kunming, Yunnan, China
NCT Number: NCT07452211
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Kunming, Yunnan, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation.
Time frame: 12 months after the ablation
12-month ablation success rate of atrial fibrillation is defined by ECG data (including ECG and 24-hour dynamic electrocardiogram (Holter)) during the effective evaluation period (blanking period to the end of 12-month follow-up), without recording AF, AFL or AT (Arrhythmia monitoring device ≥ 30 seconds).
Time frame: 30 minutes after the ablation
30 minutes after CPVI, inflow block was confirmed in all clinically relevant pulmonary veins following induction with isoproterenol.
Time frame: 12 months after the ablation
The rate of repeat ablation within 12 months.
Time frame: 3 months after the ablation
Including death, myocardial infarction, stroke or transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve palsy, systemic circulatory embolism, pericarditis*, cardiac tamponade/perforation, atrial esophageal fistula, and severe vascular access complications.
Time frame: immediately after the ablation
Total procedure time (defined as the total time from initial femoral venipuncture to final catheter removal), catheter dwell time (time between the pulsed field ablation catheter entering the left atrium and its withdrawal from the left atrium), pulse discharge time (The total time of delivering pulse energy through the pulsed field ablation catheter, single ablation time ablation times), total X-ray exposure time (the total time of X-ray imaging of the catheter).
Hangzhou Dinova EP Technology Co., Ltd
Industry
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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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