Clinical trial NCT04770142: 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
Overall status: TERMINATED
Phase: NA
Conditions: Hypertrophic Obstructive Cardiomyopathy
Keywords: Transcatheter RF ablation
Intraseptal ablation
HOCM
TauPnu
Lead sponsor: Tau-MEDICAL Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: multi-center, open label, single arm, investigator initiated exploratory pilot study
Primary purpose: DEVICE_FEASIBILITY

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change of LVOT obstruction
timeFrame: immediately after the procedure and 3 months
measure: Change of LVOT and Septum(1)
timeFrame: immediately after the procedure and 3 months
measure: Change of LVOT and Septum(2)
timeFrame: immediately after the procedure and 3 months
measure: Morphological Structural Changes in the Lesion Area
timeFrame: immediately after the procedure and 3 months
measure: Rate of adverse events as a measure of safety
timeFrame: immediately after the procedure and 3 months
Secondary outcomes:
measure: Change of LVOT obstruction
timeFrame: 6 and 12 months
measure: Change of LVOT and Septum(1)
timeFrame: 6 and 12 months
measure: Change of LVOT and Septum(2)
timeFrame: 6 and 12 months
measure: Change of LVOT and Septum(3)
timeFrame: 6 and 12 months
measure: Change of LVOT and Septum(4)
timeFrame: 6 and 12 months
measure: Change of LVOT and Septum(5)
timeFrame: 6 and 12 months
measure: Morphological Structural Changes in the Lesion Area
timeFrame: 6 and 12 months
measure: Rate of adverse events as a measure of safety
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Dalseo-gu
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
state: Dongan-gu
city: Bucheon-si
country: Korea, Republic of
facility: Sejong HOSPITAL
state: Gyeonggi-do
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnamdo
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital (CNU Hospital)
state: Jung-gu
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
state: Nam-gu
city: Ulsan
country: Korea, Republic of
facility: Ulsan Hospital
state: Nam-gu
city: Sejong
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
state: Sejong-si
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Seung-Whan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.