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

February 27, 2024 updated by: Seung-Whan Lee,MD,PhD, Tau Pnu Medical Co., Ltd.

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Bodeum7ro
      • Sejong, Bodeum7ro, Korea, Republic of, 30099
        • Not yet recruiting
        • Chungnam National University Sejong Hospital
        • Contact:
          • Jae-Hwan Lee, MD, PhD
        • Principal Investigator:
          • Jae-Hwan Lee
    • Dalseo-gu
      • Daegu, Dalseo-gu, Korea, Republic of, 42601
        • Not yet recruiting
        • Keimyung University Dongsan Hospital
        • Contact:
          • Cheol-Hyun Lee
          • Phone Number: +82-53-250-7314
        • Principal Investigator:
          • Cheol-Hyun Lee
        • Sub-Investigator:
          • In-Chul Kim
    • Dongan-gu
      • Anyang, Dongan-gu, Korea, Republic of, 14068
        • Not yet recruiting
        • Hallym University Medical Center
        • Contact:
          • Hyun-Suk Kim, MD, PhD
        • Principal Investigator:
          • Hyun-Suk Kim
        • Sub-Investigator:
          • Youn-suck Koh
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14754
        • Not yet recruiting
        • Sejong Hospital
        • Contact:
          • Young-Jin Choi
          • Phone Number: +82-1599-6677
        • Principal Investigator:
          • Young-Jin Choi
        • Sub-Investigator:
          • Ha-Uk Park
        • Sub-Investigator:
          • Chi-Hoon Kim
    • Gyeongsangnamdo
      • Yangsan, Gyeongsangnamdo, Korea, Republic of, 626-770
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yonghyun Park, MD, PhD
        • Sub-Investigator:
          • Minku Chon, MD, PhD
        • Sub-Investigator:
          • June-Hong Kim, MD, PhD
        • Sub-Investigator:
          • Kiwon Hwang, MD, PhD
        • Sub-Investigator:
          • Sanghyun Lee, MD, PhD
        • Sub-Investigator:
          • Jeongsu Kim, MD, PhD
        • Sub-Investigator:
          • Suyong Lee, MD, PhD
        • Sub-Investigator:
          • Hyunggon Je, MD, PhD
        • Sub-Investigator:
          • Kiseok Choo, MD, PhD
    • Jung-gu
      • Daejeon, Jung-gu, Korea, Republic of, 35015
        • Not yet recruiting
        • Chungnam National University Hospital (CNU Hospital)
        • Contact:
          • Jae-Hyeong Park, MD, PhD
          • Phone Number: +82-42-280-7795
        • Principal Investigator:
          • Jae-Hyeong Park
    • Nam-gu
      • Daegu, Nam-gu, Korea, Republic of, 42415
        • Not yet recruiting
        • Yeungnam University Hospital
        • Contact:
          • Woong Kim
          • Phone Number: +82-53-620-3148
        • Principal Investigator:
          • Woong Kim
        • Sub-Investigator:
          • Jung-Hee Lee
      • Ulsan, Nam-gu, Korea, Republic of, 44686
        • Not yet recruiting
        • Ulsan Hospital
        • Contact:
          • Eun-Seok Shin
          • Phone Number: +82-52-259-5000
    • Songpa-gu
      • Seoul, Songpa-gu, Korea, Republic of, 05505
        • Not yet recruiting
        • Asan Medical Center
        • Contact:
          • Seung-whan Lee, MD, PhD
          • Phone Number: +82-2-3010-3170
        • Principal Investigator:
          • Min-Soo Cho, MD, PhD
        • Sub-Investigator:
          • Gi-Byeong Nam, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).)

Exclusion Criteria:

  • Target area wall thickness ≤15mm
  • LV ejection fraction ≤30%
  • 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
  • Subjects who have cardiogenic shock and those who have an expected life expectancy of 12 months or less.
  • Subjects 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).
  • Subjects who are pregnant, or lactating, or plan pregnacy during the clinical trials
  • Subjects who are participated in other clinical trials within 1 month of enrollment
  • Subjects who are deemed not to be eligible in this study by physician's discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: immediately after the procedure and 1 month
LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram
immediately after the procedure and 1 month
Change of LVOT and Septum(1)
Time Frame: immediately after the procedure and 1 month
LVOT diameter (mm) with Echocardiogram
immediately after the procedure and 1 month
Change of LVOT and Septum(2)
Time Frame: immediately after the procedure and 1 month
Intraventricular septum(IVS) thickness (mm) with Echocardiogram
immediately after the procedure and 1 month
Morphological Structural Changes in the Lesion Area
Time Frame: immediately after the procedure and 1 month
Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI
immediately after the procedure and 1 month
Rate of adverse events as a measure of safety
Time Frame: immediately after the procedure and 1 month
Rate of composite endpoint of MACE *death, myocardial infarction, cardiac tamponade, device related acrdiac surgery, stroke
immediately after the procedure and 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of LVOT obstruction
Time Frame: 6 and 12 months
LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram
6 and 12 months
Change of LVOT and Septum(1)
Time Frame: 6 and 12 months
LVOT diameter (mm) with Echocardiogram
6 and 12 months
Change of LVOT and Septum(2)
Time Frame: 6 and 12 months
Intraventricular septum(IVS) thickness (mm) with Echocardiogram
6 and 12 months
Change of LVOT and Septum(3)
Time Frame: 6 and 12 months
Left atrial volume index (ml/m2) with Echocardiogram
6 and 12 months
Change of LVOT and Septum(4)
Time Frame: 6 and 12 months
Mitral regurgitation volume (ml) with Echocardiogram
6 and 12 months
Change of LVOT and Septum(5)
Time Frame: 6 and 12 months
Systolic anterior motion of the mitral valve (SAM) with Echocardiogram
6 and 12 months
Morphological Structural Changes in the Lesion Area
Time Frame: 6 and 12 months
Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI
6 and 12 months
Rate of adverse events as a measure of safety
Time Frame: 6 and 12 months
Rate of composite endpoint of MACE *death, myocardial infarction, cardiac tamponade, device related acrdiac surgery, stroke
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tau Pnu Medical Co., Ltd.

Investigators

  • Principal Investigator: Seung-Whan Lee, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Estimated)

April 8, 2026

Study Completion (Estimated)

August 8, 2026

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)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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