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TERMINATEDNANCT04770142

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

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

Lead sponsor: Tau-MEDICAL Co., Ltd.•9 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Tau-MEDICAL Co., Ltd.

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).

Age

20 - No limit years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 16, 2025Terms

Trial snapshot

StatusTERMINATED

PhaseNA

Enrollment5

Start dateApr 2021

Last updatedApr 16, 2025

Condition

Hypertrophic Obstructive Cardiomyopathy

Locations shown

Keimyung University Dongsan Hospital

Daegu, Dalseo-gu

Hallym University Medical Center

Anyang, Dongan-gu

Sejong HOSPITAL

Bucheon-si, Gyeonggi-do

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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