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

NCT04770142 | Terminated

• 1 other identifier: TIRA-FIM
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

Transcatheter RF ablation; Intraseptal ablation; HOCM; TauPnu

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Change of LVOT obstruction

  6 and 12 months

• Change of LVOT and Septum(1)

  6 and 12 months

• Change of LVOT and Septum(2)

  6 and 12 months

• Change of LVOT and Septum(3)

  6 and 12 months

• Change of LVOT and Septum(4)

  6 and 12 months

Study Arms (1)

TIRA

EXPERIMENTAL

treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)

Device: TIRA catheter

Interventions

TIRA catheter DEVICE

treat hypertrophic obstructive cardiomyopathy

Also known as: CA10 and ohter 3 models

TIRA

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tau-MEDICAL Co., Ltd.: lead

Study Sites (9)

Keimyung University Dongsan Hospital

Daegu, Dalseo-gu, 42601, South Korea

Location

Hallym University Medical Center

Anyang, Dongan-gu, 14068, South Korea

Location

Sejong HOSPITAL

Bucheon-si, Gyeonggi-do, 14754, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

Chungnam National University Hospital (CNU Hospital)

Daejeon, Jung-gu, 35015, South Korea

Location

Yeungnam University Hospital

Daegu, Nam-gu, 42415, South Korea

Location

Ulsan Hospital

Ulsan, Nam-gu, 44686, South Korea

Location

Chungnam National University Sejong Hospital

Sejong, Sejong-si, 30099, South Korea

Location

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

Related Publications (1)

• 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.

  PMID: 39767669 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Seung-Whan Lee, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: multi-center, open label, single arm, investigator initiated exploratory pilot study

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 25, 2021
• Study Start: April 21, 2021
• Primary Completion: July 2, 2024
• Study Completion: April 8, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

KR (9)