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

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

Detailed Description
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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).

Official Title
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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

Conditions
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Hypertrophic Obstructive Cardiomyopathy

Intervention / Treatment
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* Device: TIRA catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: multi-center, open label, single arm, investigator initiated exploratory pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIRA<br>treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices) | Device: TIRA catheter<br>* treat hypertrophic obstructive cardiomyopathy<br>* Other names: CA10 and ohter 3 models;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of LVOT obstruction | LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram | immediately after the procedure and 1 month | 
| Change of LVOT and Septum(1) | LVOT diameter (mm) with Echocardiogram | immediately after the procedure and 1 month | 
| Change of LVOT and Septum(2) | Intraventricular septum(IVS) thickness (mm) with Echocardiogram | immediately after the procedure and 1 month | 
| Morphological Structural Changes in the Lesion Area | Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI | immediately after the procedure and 1 month | 
| Rate of adverse events as a measure of safety | Rate of composite endpoint of MACE *death, myocardial infarction, cardiac tamponade, device related acrdiac surgery, stroke | immediately after the procedure and 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of LVOT obstruction | LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram | 6 and 12 months | 
| Change of LVOT and Septum(1) | LVOT diameter (mm) with Echocardiogram | 6 and 12 months | 
| Change of LVOT and Septum(2) | Intraventricular septum(IVS) thickness (mm) with Echocardiogram | 6 and 12 months | 
| Change of LVOT and Septum(3) | Left atrial volume index (ml/m2) with Echocardiogram | 6 and 12 months | 
| Change of LVOT and Septum(4) | Mitral regurgitation volume (ml) with Echocardiogram | 6 and 12 months | 
| Change of LVOT and Septum(5) | Systolic anterior motion of the mitral valve (SAM) with Echocardiogram | 6 and 12 months | 
| Morphological Structural Changes in the Lesion Area | Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI | 6 and 12 months | 
| Rate of adverse events as a measure of safety | Rate of composite endpoint of MACE *death, myocardial infarction, cardiac tamponade, device related acrdiac surgery, stroke | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter RF ablation, Intraseptal ablation, HOCM, TauPnu