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

Primary Purpose

Hypertrophic Obstructive Cardiomyopathy

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TIRA catheter
Sponsored by
Tau Pnu Medical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Hypertrophic Obstructive Cardiomyopathy focused on measuring Transcatheter RF ablation, Intraseptal ablation, HOCM, TauPnu

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chungnam National University Sejong Hospital
  • Keimyung University Dongsan Hospital
  • Hallym University Medical Center
  • Sejong HOSPITAL
  • Pusan National University Yangsan HospitalRecruiting
  • Chungnam National University Hospital (CNU Hospital)
  • Yeungnam University Hospital
  • Ulsan Hospital
  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TIRA

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2021
Last Updated
December 5, 2022
Sponsor
Tau Pnu Medical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04770142
Brief Title
First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
March 6, 2023 (Anticipated)
Study Completion Date
August 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tau Pnu Medical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Obstructive Cardiomyopathy
Keywords
Transcatheter RF ablation, Intraseptal ablation, HOCM, TauPnu

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
multi-center, open label, single arm, investigator initiated exploratory pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIRA
Arm Type
Experimental
Arm Description
treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)
Intervention Type
Device
Intervention Name(s)
TIRA catheter
Other Intervention Name(s)
CA10 and ohter 3 models
Intervention Description
treat hypertrophic obstructive cardiomyopathy
Primary Outcome Measure Information:
Title
Change of LVOT obstruction
Description
LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram
Time Frame
immediately after the procedure and 1 month
Title
Change of LVOT and Septum(1)
Description
LVOT diameter (mm) with Echocardiogram
Time Frame
immediately after the procedure and 1 month
Title
Change of LVOT and Septum(2)
Description
Intraventricular septum(IVS) thickness (mm) with Echocardiogram
Time Frame
immediately after the procedure and 1 month
Title
Morphological Structural Changes in the Lesion Area
Description
Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI
Time Frame
immediately after the procedure and 1 month
Title
Rate of adverse events as a measure of safety
Description
Rate of composite endpoint of MACE *death, myocardial infarction, cardiac tamponade, device related acrdiac surgery, stroke
Time Frame
immediately after the procedure and 1 month
Secondary Outcome Measure Information:
Title
Change of LVOT obstruction
Description
LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram
Time Frame
6 and 12 months
Title
Change of LVOT and Septum(1)
Description
LVOT diameter (mm) with Echocardiogram
Time Frame
6 and 12 months
Title
Change of LVOT and Septum(2)
Description
Intraventricular septum(IVS) thickness (mm) with Echocardiogram
Time Frame
6 and 12 months
Title
Change of LVOT and Septum(3)
Description
Left atrial volume index (ml/m2) with Echocardiogram
Time Frame
6 and 12 months
Title
Change of LVOT and Septum(4)
Description
Mitral regurgitation volume (ml) with Echocardiogram
Time Frame
6 and 12 months
Title
Change of LVOT and Septum(5)
Description
Systolic anterior motion of the mitral valve (SAM) with Echocardiogram
Time Frame
6 and 12 months
Title
Morphological Structural Changes in the Lesion Area
Description
Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI
Time Frame
6 and 12 months
Title
Rate of adverse events as a measure of safety
Description
Rate of composite endpoint of MACE *death, myocardial infarction, cardiac tamponade, device related acrdiac surgery, stroke
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Whan Lee, MD, PhD
Phone
+82553678783
Email
seungwlee@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
June-Hong Kim, MD, PhD
Phone
+82553678783
Email
junehongk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Whan Lee, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungnam National University Sejong Hospital
City
Sejong
State/Province
Bodeum7ro
ZIP/Postal Code
30099
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Hwan Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jae-Hwan Lee
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
State/Province
Dalseo-gu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheol-Hyun Lee
Phone
+82-53-250-7314
First Name & Middle Initial & Last Name & Degree
Cheol-Hyun Lee
First Name & Middle Initial & Last Name & Degree
In-Chul Kim
Facility Name
Hallym University Medical Center
City
Anyang
State/Province
Dongan-gu
ZIP/Postal Code
14068
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-Suk Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hyun-Suk Kim
First Name & Middle Initial & Last Name & Degree
Youn-suck Koh
Facility Name
Sejong HOSPITAL
City
Bucheon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14754
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Jin Choi
Phone
+82-1599-6677
First Name & Middle Initial & Last Name & Degree
Young-Jin Choi
First Name & Middle Initial & Last Name & Degree
Ha-Uk Park
First Name & Middle Initial & Last Name & Degree
Chi-Hoon Kim
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnamdo
ZIP/Postal Code
626-770
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
June-Hong Kim, MD, Ph D
Phone
82-55-360-1548
Email
junehongk@gmail.com
First Name & Middle Initial & Last Name & Degree
Minku Chon, MD, PhD
Phone
82-55-360-1458
Email
chonmingu@gmail.com
First Name & Middle Initial & Last Name & Degree
Yonghyun Park, MD, PhD
First Name & Middle Initial & Last Name & Degree
Minku Chon, MD, PhD
First Name & Middle Initial & Last Name & Degree
June-Hong Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kiwon Hwang, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sanghyun Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jeongsu Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Suyong Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hyunggon Je, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kiseok Choo, MD, PhD
Facility Name
Chungnam National University Hospital (CNU Hospital)
City
Daejeon
State/Province
Jung-gu
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Hyeong Park, MD, PhD
Phone
+82-42-280-7795
First Name & Middle Initial & Last Name & Degree
Jae-Hyeong Park
Facility Name
Yeungnam University Hospital
City
Daegu
State/Province
Nam-gu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woong Kim
Phone
+82-53-620-3148
First Name & Middle Initial & Last Name & Degree
Woong Kim
First Name & Middle Initial & Last Name & Degree
Jung-Hee Lee
Facility Name
Ulsan Hospital
City
Ulsan
State/Province
Nam-gu
ZIP/Postal Code
44686
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Seok Shin
Phone
+82-52-259-5000
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-whan Lee, MD, PhD
Phone
+82-2-3010-3170
First Name & Middle Initial & Last Name & Degree
Min-Soo Cho, MD, PhD
First Name & Middle Initial & Last Name & Degree
Gi-Byeong Nam, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33145462
Citation
Shin ES, Chon MK, Jun EJ, Park YH, Lee SH, Kim JS, Shin DH, Lee SY, Cho MS, Lee SW, Reinthaler M, Park JW, Nam GB, Lederman RJ, Won Y, Kim JH. Septal Reduction Using Transvenous Intramyocardial Cerclage Radiofrequency Ablation: Preclinical Feasibility. JACC Basic Transl Sci. 2020 Sep 30;5(10):988-998. doi: 10.1016/j.jacbts.2020.08.006. eCollection 2020 Oct.
Results Reference
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First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation

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