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

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 antagonistsshould be given for at least 3 months.)

• Patients with left ventricular effusion gradient (LVOT) greater than (1) 30 mmHg atrest or (2) at least 50 mmHg at physiological exercise/dobutamineadministration/balsalva manuver. (The pressure difference due to the left ventricledrain must be the proximal mitral valve-septal contact by the systolic motion ofmitral valve (SAM).)

• Patients who voluntarily decide to participate in this clinical trial and providewritten informed consent.

• Patients who are able to understand and follow instructions and participate for theentire 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 orvenogram

• Conduction disturbance; LBBB or RBBB

• Advanced AV block without permanent pacemaker

• Subjects who have experience in performing vascular stent procedures (PCI) or CABGon 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 expectancyof 12 months or less.

• Patients with other valve diseases (companion disease) that require surgicaltreatment (in this case, Systolic motion of the mitral valve (SAM) caused bysystolic 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