Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
treat hypertrophic obstructive cardiomyopathy
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, South Korea
Hallym University Medical Center
Anyang, Dongan-gu, South Korea
Sejong HOSPITAL
Bucheon-si, Gyeonggi-do, South Korea
Pusan National University Yangsan Hospital
Change of LVOT obstruction
LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram
Time frame: immediately after the procedure and 3 months
Change of LVOT and Septum(1)
LVOT diameter (mm) with Echocardiogram
Time frame: immediately after the procedure and 3 months
Change of LVOT and Septum(2)
Intraventricular septum(IVS) thickness (mm) with Echocardiogram
Time frame: immediately after the procedure and 3 months
Morphological Structural Changes in the Lesion Area
Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI
Time frame: immediately after the procedure and 3 months
Rate of adverse events as a measure of safety
Adverse Events (AEs): Frequency (Number of Events) \*with particular focus on serious adverse events (SAEs) and serious adverse device effects (SADEs).
Time frame: immediately after the procedure and 3 months
Change of LVOT obstruction
LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram
Time frame: 6 and 12 months
Change of LVOT and Septum(1)
LVOT diameter (mm) with Echocardiogram
Time frame: 6 and 12 months
Change of LVOT and Septum(2)
Intraventricular septum(IVS) thickness (mm) with Echocardiogram
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Yangsan, Gyeongsangnam-do, South Korea
Chungnam National University Hospital (CNU Hospital)
Daejeon, Jung-gu, South Korea
Yeungnam University Hospital
Daegu, Nam-gu, South Korea
Ulsan Hospital
Ulsan, Nam-gu, South Korea
Chungnam National University Sejong Hospital
Sejong, Sejong-si, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Time frame: 6 and 12 months
Change of LVOT and Septum(3)
Left atrial volume index (ml/m2) with Echocardiogram
Time frame: 6 and 12 months
Change of LVOT and Septum(4)
Mitral regurgitation volume (ml) with Echocardiogram
Time frame: 6 and 12 months
Change of LVOT and Septum(5)
Systolic anterior motion of the mitral valve (SAM) with Echocardiogram
Time frame: 6 and 12 months
Morphological Structural Changes in the Lesion Area
Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI
Time frame: 6 and 12 months
Rate of adverse events as a measure of safety
Adverse Events (AEs): Frequency (Number of Events) \*with particular focus on serious adverse events (SAEs) and serious adverse device effects (SADEs).
Time frame: 6 and 12 months