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
NCT number | NCT04770142 |
Other study ID # | TIRA-FIM |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 20, 2021 |
Est. completion date | August 8, 2026 |
Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Tau Pnu Medical Co., Ltd. |
Korea, Republic of,
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
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 |
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