A Prospective, Multi-center, Randomized, Single-blind, Non-inferiority Confirmatory Study Designed to Compare and Assess Efficacy and Safety Between "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 "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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- First-pass TSP Success Rate (percent)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Diagnosed with one of the following cardiac disorders as shown in the medical record:
- •[Symptomatic arrhythmia]
- •"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
- •Symptoms: fatigue, palpitation, dyspnea, chest discomfort, sleep disorders, mental stress
- •Paroxysmal atrial fibrillation (stopping within 48 hours without any treatment; restoring the sinus rhythm with cardioversion within 7 days)
- •Persistent atrial fibrillation (persisting for ≥ 7 days; including sinus rhythm restoration with direct-current cardioversion (DCC) or pharmacological cardioversion after the persistence)
- •Long-standing persistent atrial fibrillation (persisting for ≥ 1 year; including cases requiring cardioversion)
- •Permanent atrial fibrillation (The patient and healthcare provider accept atrial fibrillation and do not consider cardioversion; if cardioversion is considered, the atrial fibrillation is reclassified as long-standing persistent atrial fibrillation)
- •"Paroxysmal Supraventricular Tachycardia" diagnostics
- •= Clinical feature: The heart beats regularly 150 to 200 times per minute; the start and end of paroxysmal supraventricular tachycardia are clearly recognizable; these occur unexpectedly and stop abruptly.
- •"Ectopic Atrial Rhythm Tachycardia" diagnostics
- •= Clinical feature: Heart rhythm of less than 250 beats per minute; morphologic difference from P waves in the sinus rhythm; P waves that precede QRS waves are identifiable.
- •"Ventricular Tachycardia" diagnostics = Clinical feature: Wide QRS waves appear in succession with a rapid ventricular rate of ≥ 100 beats per minute; the patients is diagnosed with persistent ventricular tachycardia if tachycardia persists for ≥ 30 seconds but with non-persistent ventricular tachycardia if not applicable.
- •"Arrhythmia requiring left atrial access, including left atrial appendage occlusion, in the left atrium" diagnostics = Clinical feature: moderate or higher risk of stroke, risk of bleeding, or contraindication to anticoagulation therapy
- •[Symptomatic mitral stenosis]
- •"Mitral Stenosis requiring percutaneous mitral valvuloplasty through left atrial access" diagnostics
- •Diagnostic criteria: confirmation of mitral stenosis with echocardiography and assessment of severity
- •Symptoms: dyspnea; shortness of breath even at rest or inability to sleep in a supine position if dyspnea worsens; may accompanied by coughing, sputum, and chest pain.
- •Understood this clinical study and voluntarily signed the informed consent form (ICF)1
排除标准
- •[For symptomatic arrhythmia and mitral stenosis] If any of the following applies, you cannot participate in this clinical trial.1,26,37,45,46
- •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.
- •Unstable angina.
- •Pre-existing hemidiaphragmatic paralysis
- •Contraindication to anticoagulation or radiocontrast materials
- •liver disease (including active hepatitis) and kidney disease.
- •Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
- •Malignant tumors or hematological diseases or life expectancy of less than one (1) year.
- •Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study
- •Unwilling or unable to comply fully with study procedures and follow-up
- •A pregnant woman, a woman planning on becoming pregnant, or a lactating woman.
- •Ineligible for study participation in the judgment of the investigator.
研究组 & 干预措施
Radiofrequency energy needle
Radiofrequency energy needle(TS-RF Needle) for transseptal access
干预措施: TS-RF Transseptal Needle (Device)
Mechanical needle
Mechanical needle(BRK Transseptal Needle) for transseptal access
干预措施: BRK Transseptal Needle (Device)
结局指标
主要结局
First-pass TSP Success Rate (percent)
时间窗: Day of procedure
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).
次要结局
- TSP Time (Second)(Day of procedure)
- Needle cross-over between the study and control groups(Day of procedure)
- Intra-TSP procedural device-associated complications(Day of procedure)
- Complications(for 2 weeks after the procedure)
- Fluoroscopy Time (Second) for TSP(Day of procedure)
- Changes in patient's quality of life(before the procedure (baseline) and at 2 weeks after the procedure.)