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.
The efficacy and safety of radiofrequency (RF) needles in transseptal puncture have been well established through several comparative clinical studies. In foreign countries, RF needles have already been used for transseptal puncture for more than 20 years since the FDA approval of the first RF Needle. However, in Korea, despite the fact that it has been approximately 30 years since the initiation of radiofrequency catheter ablation (RFCA) for the treatment of arrhythmia, only the conventional mechanical needles have still been available after authorization for transseptal puncture that is the key for the treatment of cardiac disorders such as mitral stenosis as well as a part of RFCA for the treatment of arrhythmia. Therefore, this study aims 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Apply radiofrequency energy to the electrode tip via the TS-RF Generator and puncture the atrial septum
Cross and puncture the atrial septum with the BRK Transseptal Needle
Bucheon Sejong Hospital
Bucheon-si, South Korea
RECRUITINGFirst-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).
Time frame: Day of procedure
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).
Time frame: Day of procedure
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.
Time frame: Day of procedure
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)
Time frame: Day of procedure
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).
Time frame: Day of procedure
Changes in patient's quality of life
Check the improvement in patient's quality of life by measuring the degree of discomfort due to symptomatic arrhythmia or mitral stenosis before the procedure (baseline) and at 2 weeks after the procedure. Calculate and compare group-specific mean changes in EQ-5D-5L and EQ-VAS before the procedure (baseline) and at the follow-up visit 2 weeks after the procedure. It consists of 5 multiple-choice questions asking about current health status and 1 question (visual analogue scale, VAS) that displays subjective health level (0 to 100 points) in the form of a thermometer.
Time frame: before the procedure (baseline) and at 2 weeks after the procedure.
Complications
Check the complications collected during the hospitalization period within 7 days immediately after the procedure and at the follow-up visit 2 weeks after the procedure, including the following two durations:. * 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
Time frame: for 2 weeks after the procedure
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