The Study for Evaluation of Safety and Efficacy of Transcatheter RF Ablation System (TIRA Catheter) to Treat Hypertrophic Obstructive Cardiomyopathy : Multi-center, Open Label, Single Arm, Investigator Initiated Exploratory Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 18
- 主要终点
- Change of LVOT obstruction
研究概览
简要总结
Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.
详细描述
The objective of this multi-center, open label, single arm, investigator initiated exploratory pilot study is to evaluation of safety and efficacy of transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices), in treating hypertrophic obstructive cardiomyopathy(HOCM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 20 years or older
- •NYHA(New York Heart Association) Class Ⅱ to Ⅳ in spite of optimal medical treatment. (For optimal medical treatment, β-blocker or diuretic such as calcium antagonists should be given for at least 3 months.)
- •Patients with left ventricular effusion gradient (LVOT) greater than (1) 30 mmHg at rest or (2) at least 50 mmHg at physiological exercise/dobutamine administration/balsalva manuver. (The pressure difference due to the left ventricle drain must be the proximal mitral valve-septal contact by the systolic motion of mitral valve (SAM).)
- •Patients who voluntarily decide to participate in this clinical trial and provide written informed consent.
- •Patients who are able to understand and follow instructions and participate for the entire duration of the clinical trial.
排除标准
- •Target area wall thickness ≤15mm
- •LV ejection fraction ≤40%
- •Subjects who have unsuitable septal vein and coronary sinus anatomy by cardiac CT or venogram
- •Conduction disturbance; LBBB or RBBB
- •Advanced AV block without permanent pacemaker
- •Subjects who have experience in performing vascular stent procedures (PCI) or CABG on coronary arteries close to the coronary sinus within 3 months.
- •Severe pulmonary HTN ≥70mmHg
- •Patients who have cardiogenic shock and those who have an expected life expectancy of 12 months or less.
- •Patients with other valve diseases (companion disease) that require surgical treatment (in this case, Systolic motion of the mitral valve (SAM) caused by systolic myocardia is not considered a companion disease).
- •Patients who are pregnant, or lactating, or plan pregnacy during the clinical trials
- •Patients who are participated in other clinical trials within 1 month of enrollment
- •Patients who are deemed not to be eligible in this study by physician's discretion
研究组 & 干预措施
TIRA
treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)
干预措施: TIRA catheter (Device)
结局指标
主要结局
Change of LVOT obstruction
时间窗: immediately after the procedure and 3 months
LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram
Change of LVOT and Septum(1)
时间窗: immediately after the procedure and 3 months
LVOT diameter (mm) with Echocardiogram
Change of LVOT and Septum(2)
时间窗: immediately after the procedure and 3 months
Intraventricular septum(IVS) thickness (mm) with Echocardiogram
Morphological Structural Changes in the Lesion Area
时间窗: immediately after the procedure and 3 months
Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI
Rate of adverse events as a measure of safety
时间窗: immediately after the procedure and 3 months
Adverse Events (AEs): Frequency (Number of Events) \*with particular focus on serious adverse events (SAEs) and serious adverse device effects (SADEs).
次要结局
- Change of LVOT and Septum(1)(6 and 12 months)
- Change of LVOT obstruction(6 and 12 months)
- Change of LVOT and Septum(2)(6 and 12 months)
- Change of LVOT and Septum(3)(6 and 12 months)
- Change of LVOT and Septum(4)(6 and 12 months)
- Change of LVOT and Septum(5)(6 and 12 months)
- Morphological Structural Changes in the Lesion Area(6 and 12 months)
- Rate of adverse events as a measure of safety(6 and 12 months)
研究者
Seung-Whan Lee,MD,PhD
Professor
Asan Medical Center