An interventional study of TIRA catheter in Hypertrophic Obstructive Cardiomyopathy, sponsored by Tau-MEDICAL Co., Ltd.. Terminated at 9 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Tau-MEDICAL Co., Ltd. · Not applicable, Interventional, and Device feasibility
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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).
363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 180 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Browse Cardiomyopathy, Hypertrophic studies →Tau-MEDICAL Co., Ltd. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)
Device: TIRA catheter
treat hypertrophic obstructive cardiomyopathy
Also known as: CA10 and ohter 3 models
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
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
Ran from Apr 2021 to primary completion in Jul 2024, 38 months.
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This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Cardiomyopathy, Hypertrophic →
Tau-MEDICAL Co., Ltd.