This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGAcute procedural success
Acute procedural success is defined as the creation of bidirectional conduction block across the cavo-tricuspid isthmus immediately and 30 minutes after ablation.
Time frame: immediately after the procedure
Chronic success
Chronic success is defined as the absence of recurrent atrial flutter at 6 months post-ablation according to electrocardiogram data, including electrocardiogram, 24-hour Holter.
Time frame: 6 months after procedure
Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time
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)
Time frame: immediately after the procedure
Incidence of device-related major adverse events (MAE) within 7 days after ablation
Device-related MAE includes death, myocardial infarction, pulmonary embolism, stroke /TIA, severe pericardial effusion, and complete atrioventricular block.
Time frame: within 7 days after ablation
Incidence of device-related severe adverse events (SAE)
Device-related SAE refers to a device-related event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
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Time frame: 3 months and 6 months after procedure