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Hypertrophic Obstructive CardiomyopathyNCT04770142

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

A study testing TIRA catheter in people with Hypertrophic Obstructive Cardiomyopathy, run by Tau-MEDICAL Co., Ltd. at 9 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 20 years and older
Conditions the study is for
Hypertrophic Obstructive Cardiomyopathy
What is being tested?
TIRA catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
9 sitesSouth Korea
Study dates
21 Apr 2021to 8 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Hallym University Medical Center

    Anyang, Dongan-gu, 14068

  • Sejong HOSPITAL

    Bucheon-si, Gyeonggi-do, 14754

  • Keimyung University Dongsan Hospital

    Daegu, Dalseo-gu, 42601

  • Yeungnam University Hospital

    Daegu, Nam-gu, 42415

  • Chungnam National University Hospital (CNU Hospital)

    Daejeon, Jung-gu, 35015

  • Chungnam National University Sejong Hospital

    Sejong, Sejong-si, 30099

  • Asan Medical Center

    Seoul, Songpa-gu, 05505

  • Ulsan Hospital

    Ulsan, Nam-gu, 44686

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 626-770

Other trials in South Korea

About this study

Official title: 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

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

Read the 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).

Being tested
TIRA catheter
Keywords
Transcatheter RF ablation, Intraseptal ablation, HOCM, TauPnu
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TIRA catheterDevice

    Also called CA10 and ohter 3 models

    treat hypertrophic obstructive cardiomyopathy

Study groups in NCT04770142
Study groupRoleWhat they receive
TIRAExperimentaltreated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)
Receives: Device: TIRA catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of LVOT obstruction

    LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram

    Measured: immediately after the procedure and 3 months

  2. Change of LVOT and Septum(1)

    LVOT diameter (mm) with Echocardiogram

    Measured: immediately after the procedure and 3 months

  3. Change of LVOT and Septum(2)

    Intraventricular septum(IVS) thickness (mm) with Echocardiogram

    Measured: immediately after the procedure and 3 months

  4. Morphological Structural Changes in the Lesion Area

    Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI

    Measured: immediately after the procedure and 3 months

  5. 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).

    Measured: immediately after the procedure and 3 months

Secondary outcomes (8)

  1. Change of LVOT obstruction

    LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram

    Measured: 6 and 12 months

  2. Change of LVOT and Septum(1)

    LVOT diameter (mm) with Echocardiogram

    Measured: 6 and 12 months

  3. Change of LVOT and Septum(2)

    Intraventricular septum(IVS) thickness (mm) with Echocardiogram

    Measured: 6 and 12 months

  4. Change of LVOT and Septum(3)

    Left atrial volume index (ml/m2) with Echocardiogram

    Measured: 6 and 12 months

  5. Change of LVOT and Septum(4)

    Mitral regurgitation volume (ml) with Echocardiogram

    Measured: 6 and 12 months

  6. Change of LVOT and Septum(5)

    Systolic anterior motion of the mitral valve (SAM) with Echocardiogram

    Measured: 6 and 12 months

  7. Morphological Structural Changes in the Lesion Area

    Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI

    Measured: 6 and 12 months

  8. 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).

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2021
  2. Study start21 Apr 2021
  3. Primary completion2 Jul 2024
  4. Study completion8 Apr 2025

Why it stopped: During the course of the clinical trial, sufficient subject enrollment was not achieved. As the recruitment of additional subjects was considered practically unfeasible, the clinical trial was terminated early.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
multi-center, open label, single arm, investigator initiated exploratory pilot study
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04770142
Sponsor's protocol ID
TIRA-FIM
Status last verified
Apr 2025
First submitted
17 Feb 2021
Last updated
16 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Oh JS, Seo JY, Lee CM, Jung SJ, Kim JH, Chon MK. Trans-Coronary Sinus Intra-Septal Radiofrequency Ablation (TIRA) for Hypertrophic Obstructive Cardiomyopathy: First-in-Human Results. Biomedicines. 2024 Dec 4;12(12):2762. doi: 10.3390/biomedicines12122762.

    PubMed 39767669

Questions about this trial

What is this clinical trial studying?

A study testing TIRA catheter in people with Hypertrophic Obstructive Cardiomyopathy, run by Tau-MEDICAL Co., Ltd. at 9 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: During the course of the clinical trial, sufficient subject enrollment was not achieved. As the recruitment of additional subjects was considered practically unfeasible, the clinical trial was terminated early.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of LVOT obstruction (time frame: immediately after the procedure and 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04770142, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.

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