Status:
TERMINATED
First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation
Lead Sponsor:
Tau-MEDICAL Co., Ltd.
Conditions:
Hypertrophic Obstructive Cardiomyopathy
Eligibility:
All Genders
20+ years
Phase:
NA
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 (TIR...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04770142
Start Date
April 21 2021
End Date
April 8 2025
Last Update
April 16 2025
Active Locations (9)
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1
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, South Korea, 42601
2
Hallym University Medical Center
Anyang, Dongan-gu, South Korea, 14068
3
Sejong HOSPITAL
Bucheon-si, Gyeonggi-do, South Korea, 14754
4
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 626-770