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

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.

Study Overview

• Status: Terminated
• Conditions: Hypertrophic Obstructive Cardiomyopathy
• Intervention / Treatment: Device: TIRA catheter

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).

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dalseo-gu
    • Daegu, Dalseo-gu, Korea, Republic of, 42601
      • Keimyung University Dongsan Hospital
  • Dongan-gu
    • Anyang, Dongan-gu, Korea, Republic of, 14068
      • Hallym University Medical Center
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14754
      • Sejong Hospital
  • Gyeongsangnamdo
    • Yangsan, Gyeongsangnamdo, Korea, Republic of, 626-770
      • Pusan National University Yangsan Hospital
  • Jung-gu
    • Daejeon, Jung-gu, Korea, Republic of, 35015
      • Chungnam National University Hospital (CNU Hospital)
  • Nam-gu
    • Daegu, Nam-gu, Korea, Republic of, 42415
      • Yeungnam University Hospital
    • Ulsan, Nam-gu, Korea, Republic of, 44686
      • Ulsan Hospital
  • Sejong-si
    • Sejong, Sejong-si, Korea, Republic of, 30099
      • Chungnam National University Sejong Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 05505
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIRA; treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)	Device: TIRA catheter; treat hypertrophic obstructive cardiomyopathy; Other Names: CA10 and ohter 3 models

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of LVOT obstruction	LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram	immediately after the procedure and 3 months
Change of LVOT and Septum(1)	LVOT diameter (mm) with Echocardiogram	immediately after the procedure and 3 months
Change of LVOT and Septum(2)	Intraventricular septum(IVS) thickness (mm) with Echocardiogram	immediately after the procedure and 3 months
Morphological Structural Changes in the Lesion Area	Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI	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).	immediately after the procedure and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of LVOT obstruction	LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram	6 and 12 months
Change of LVOT and Septum(1)	LVOT diameter (mm) with Echocardiogram	6 and 12 months
Change of LVOT and Septum(2)	Intraventricular septum(IVS) thickness (mm) with Echocardiogram	6 and 12 months
Change of LVOT and Septum(3)	Left atrial volume index (ml/m2) with Echocardiogram	6 and 12 months
Change of LVOT and Septum(4)	Mitral regurgitation volume (ml) with Echocardiogram	6 and 12 months
Change of LVOT and Septum(5)	Systolic anterior motion of the mitral valve (SAM) with Echocardiogram	6 and 12 months
Morphological Structural Changes in the Lesion Area	Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI	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).	6 and 12 months

Collaborators and Investigators

• Sponsor: Tau-MEDICAL Co., Ltd.
• Investigators: Principal Investigator: Seung-Whan Lee, MD, PhD, Asan Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): July 2, 2024
• Study Completion (Actual): April 8, 2025

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Transcatheter RF ablation; Intraseptal ablation; HOCM; TauPnu
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
• Other Study ID Numbers: TIRA-FIM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No