First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation

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

Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.

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).

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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