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

Tau-MEDICAL Co., Ltd.

Status

Terminated

Conditions

Hypertrophic Obstructive Cardiomyopathy

Treatments

Device: TIRA catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT04770142

TIRA-FIM

Details and patient eligibility

About

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

Full description

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).

Enrollment

5 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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