Hypertrophic Obstructive Cardiomyopathy
Conditions
Keywords
Transcatheter RF ablation, Intraseptal ablation, HOCM, TauPnu
Brief summary
Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.
Detailed 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).
Interventions
DEVICETIRA catheter
treat hypertrophic obstructive cardiomyopathy
Sponsors
Tau-MEDICAL Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
multi-center, open label, single arm, investigator initiated exploratory pilot study
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of LVOT obstruction | immediately after the procedure and 3 months | LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram |
| Change of LVOT and Septum(1) | immediately after the procedure and 3 months | LVOT diameter (mm) with Echocardiogram |
| Change of LVOT and Septum(2) | immediately after the procedure and 3 months | Intraventricular septum(IVS) thickness (mm) with Echocardiogram |
| Morphological Structural Changes in the Lesion Area | immediately after the procedure and 3 months | Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI |
| Rate of adverse events as a measure of safety | immediately after the procedure and 3 months | Adverse Events (AEs): Frequency (Number of Events) \*with particular focus on serious adverse events (SAEs) and serious adverse device effects (SADEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of LVOT and Septum(1) | 6 and 12 months | LVOT diameter (mm) with Echocardiogram |
| Change of LVOT and Septum(4) | 6 and 12 months | Mitral regurgitation volume (ml) with Echocardiogram |
| Change of LVOT and Septum(3) | 6 and 12 months | Left atrial volume index (ml/m2) with Echocardiogram |
| Change of LVOT and Septum(2) | 6 and 12 months | Intraventricular septum(IVS) thickness (mm) with Echocardiogram |
| Change of LVOT and Septum(5) | 6 and 12 months | Systolic anterior motion of the mitral valve (SAM) with Echocardiogram |
| Morphological Structural Changes in the Lesion Area | 6 and 12 months | Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI |
| Rate of adverse events as a measure of safety | 6 and 12 months | Adverse Events (AEs): Frequency (Number of Events) \*with particular focus on serious adverse events (SAEs) and serious adverse device effects (SADEs). |
| Change of LVOT obstruction | 6 and 12 months | LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram |
Countries
South Korea
Outcome results
None listed