The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device.
≥ 18 years of age
"Atrial fibrillation" diagnostics (including paroxysmal, persistent, long-standing persistent and permanent atrial fibrillation)
Diagnostic criteria: atrial fibrillation lasting ≥ 30 seconds as a result of standard 12-lead electrocardiogram (ECG) or single-lead ECG
ECG feature: irregular R-R interval, lack of visible P waves, irregular atrial activation
Patients with significant congenital heart defects, such as atrial septal defect or pulmonary vein (PV) abnormalities (excluding patent foramen ovale (PFO)).
Thrombus in the left atrium
Atrial fibrillation to reversible causes (e.g. hyperthyroidism, thoracic surgery)
Known or suspected left atrial myxoma.
Parallel
TS-RF Transseptal Needle
DeviceApply radiofrequency energy to the electrode tip via the TS-RF Generator and puncture the atrial septum
BRK Transseptal Needle
DeviceCross and puncture the atrial septum with the BRK Transseptal Needle
First-pass TSP Success Rate (percent)
Probability that the needle crosses from the superior vena cava to the fossa ovalis and its left atrial access is identified at a time by fluoroscopy, transesophageal echocardiography (TEE), or intracardiac echocardiography (ICE).
TSP Time (Second)
Time from the point where the needle crosses from the superior vena cava to the fossa ovalis to the point where its left atrial access is identified by fluoroscopy, transesophageal echocardiography (TEE), or intracardiac echocardiography (ICE).
Fluoroscopy Time (Second) for TSP
Time from the point where invasive vascular monitoring is initiated with fluoroscopy following the femoral venous puncture and then the needle inserted into the femoral vein is visible on the fluoroscope's fluorescent screen to the point where the needle tip's left atrial access after TSP is identified.
Needle cross-over between the study and control groups
Perform TSP by switching the needle from the BRK needle in the control group to the TS-RF needle in the study group, or from the TS-RF needle in the study group to the BRK needle in the control group. Collect the data based on the recorded videos and procedure record sheets. (Number of subjects who switched needles and percentage in each group)
Intra-TSP procedural device-associated complications
Collect and total the numbers of intra-TSP procedural device-associated complications for each group based on the procedure record sheets and then calculate and compare the group-specific incidence rates (percent).
Intra-TSP procedural Adverse Events
Types and numbers of adverse events, including all complications that occurred during TSP, such as perforations, damages and bleedings in tissues other than the atrial septum due to needles, sheaths, dilators, and other catheters, replacement with the same needle product, and deterioration of patient's vital signs.
Overall Adverse Events
Types and numbers of all adverse events including all complications occurring from the time of subject enrollment to the end of follow-up visit at 2 weeks after TSP, including the following three durations: * From the subject enrollment to the end of TSP * From the end of TSP to the end of hospitalization within 7 days thereafter * From the discharge to the follow-up visit at 2 weeks after TSP
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Starmed
Lead sponsor
Helptrial
Collaborator
