Clinical trial: First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation (NCT04770142)

Eligibility criteria:
Inclusion Criteria:

          -  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).)

        Exclusion Criteria:

          -  Target area wall thickness ≤15mm

          -  LV ejection fraction ≤30%

          -  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

          -  Subjects who have cardiogenic shock and those who have an expected life expectancy of
             12 months or less.

          -  Subjects 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).

          -  Subjects who are pregnant, or lactating, or plan pregnacy during the clinical trials

          -  Subjects who are participated in other clinical trials within 1 month of enrollment

          -  Subjects who are deemed not to be eligible in this study by physician's discretion
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.


Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? Entailment