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

Hypertrophic Obstructive Cardiomyopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04770142
• Other study ID #: TIRA-FIM
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: August 8, 2026

Study information

• Verified date: February 2024
• Source: Tau Pnu Medical Co., Ltd.
• Contact: Seung-Whan Lee, MD, PhD
• Phone: +82553678783
• Email: seungwlee[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: August 8, 2026
• Est. primary completion date: April 8, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• NYHA(New York Heart Association) Class ? to ? in spite of optimal medical treatment. (For optimal medical treatment, ß-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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy

Intervention

Device:
• TIRA catheter
treat hypertrophic obstructive cardiomyopathy

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang	Dongan-gu
Korea, Republic of	Sejong HOSPITAL	Bucheon-si	Gyeonggi-do
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu	Dalseo-gu
Korea, Republic of	Yeungnam University Hospital	Daegu	Nam-gu
Korea, Republic of	Chungnam National University Hospital (CNU Hospital)	Daejeon	Jung-gu
Korea, Republic of	Chungnam National University Sejong Hospital	Sejong	Bodeum7ro
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Ulsan Hospital	Ulsan	Nam-gu
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
Tau Pnu Medical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

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