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During the course of the clinical trial, sufficient subject enrollment was not achieved. As the recruitment of additional subjects was considered practically unfeasible, the clinical trial was terminated early.
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Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIRA | Experimental | treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIRA catheter | Device | treat hypertrophic obstructive cardiomyopathy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of LVOT obstruction | LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram | immediately after the procedure and 3 months |
| Change of LVOT and Septum(1) | LVOT diameter (mm) with Echocardiogram | immediately after the procedure and 3 months |
| Change of LVOT and Septum(2) | Intraventricular septum(IVS) thickness (mm) with Echocardiogram | immediately after the procedure and 3 months |
| Morphological Structural Changes in the Lesion Area | Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI | immediately after the procedure and 3 months |
| Rate of adverse events as a measure of safety | Adverse Events (AEs): Frequency (Number of Events) *with particular focus on serious adverse events (SAEs) and serious adverse device effects (SADEs). | immediately after the procedure and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of LVOT obstruction | LVOT gradient (mmHg) ; resting / valsalva maneuver with Echocardiogram | 6 and 12 months |
| Change of LVOT and Septum(1) | LVOT diameter (mm) with Echocardiogram |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Whan Lee, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Hospital | Daegu | Dalseo-gu | 42601 | South Korea | ||
| Hallym University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39767669 | Result | 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. |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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multi-center, open label, single arm, investigator initiated exploratory pilot study
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| 6 and 12 months |
| Change of LVOT and Septum(2) | Intraventricular septum(IVS) thickness (mm) with Echocardiogram | 6 and 12 months |
| Change of LVOT and Septum(3) | Left atrial volume index (ml/m2) with Echocardiogram | 6 and 12 months |
| Change of LVOT and Septum(4) | Mitral regurgitation volume (ml) with Echocardiogram | 6 and 12 months |
| Change of LVOT and Septum(5) | Systolic anterior motion of the mitral valve (SAM) with Echocardiogram | 6 and 12 months |
| Morphological Structural Changes in the Lesion Area | Intraventricular septum(IVS) thickness (mm) with cardiac CT and MRI | 6 and 12 months |
| Rate of adverse events as a measure of safety | Adverse Events (AEs): Frequency (Number of Events) *with particular focus on serious adverse events (SAEs) and serious adverse device effects (SADEs). | 6 and 12 months |
| Anyang |
| Dongan-gu |
| 14068 |
| South Korea |
| Sejong HOSPITAL | Bucheon-si | Gyeonggi-do | 14754 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | 626-770 | South Korea |
| Chungnam National University Hospital (CNU Hospital) | Daejeon | Jung-gu | 35015 | South Korea |
| Yeungnam University Hospital | Daegu | Nam-gu | 42415 | South Korea |
| Ulsan Hospital | Ulsan | Nam-gu | 44686 | South Korea |
| Chungnam National University Sejong Hospital | Sejong | Sejong-si | 30099 | South Korea |
| Asan Medical Center | Seoul | Songpa-gu | 05505 | South Korea |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |