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| Name | Class |
|---|---|
| Hangzhou Nuo Cheng Medical Instrument Co.,Ltd | UNKNOWN |
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Objective to investigate the safety and effectiveness of Echocardiography-guided radiofrequency ablation in patients with Hypertrophic obstructive Cardiomyopathy (HOCM).
Percutaneous intramyocardial septal radiofrequency ablation (Liwen Procedure) is a safe and effective treatment approach for Hypertrophic obstructive Cardiomyopathy and results in sustained improvement in exercise capacity, persistent in reducing Left Ventricle Outflow Tract (LVOT) gradient, and sustained improvement in cardiac function.
In patients with disabling symptoms caused by Hypertrophic obstructive Cardiomyopathy (HOCM),Echocardiography-guided radiofrequency ablation could be a less invasive treatment option.
Percutaneous intramyocardial septal radiofrequency ablation (Liwen Procedure) is a new method for the diagnosis or treatment of heart disease by using a special diagnosis and treatment device to the heart target area under the guidance of image technology. The method breaks through the worldwide problem of the minimally invasive diagnosis and treatment of the myocardium on the beating heart, so as to avoid the X-ray radiation and contrast agent damage .
As a new pathway of cardiac disease intervention, Liwen Procedure can be used in congenital heart disease, myocardial biopsies, drug injection, cell implantation and instrument implantation in addition to Hypertrophic Cardiomyopathy and cardiac tumors. It has important clinical value and broad application prospect.
In this study, Liwen RF radiofrequency ablation system was used to treat HOCM , and evaluate its safety and effectiveness , in order to provide a new medical device for Liwen Procedure of HOCM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertrophic Obstructive Cardiomyopathy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM). | Procedure | Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM). |
| Measure | Description | Time Frame |
|---|---|---|
| Main adverse event | Any instrument or surgery-related complications, including but not limited to death, emergency surgery, severe pericardial tamponade requiring pericardiocentesis or surgery, bleeding, surgery-related stroke. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Instrument success | Radiofrequency ablation system instruments reach the desired treatment site and successfully complete ablation,and remove the system successfully. | 30 days |
| Operation success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liwen Liu, MD | Contact | 86-13571975528 | liuliwencrt@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33628143 | Derived | Han C, Zhou M, Hu R, Wang B, Zuo L, Li J, Ta S, Hsi DH, Liu J, Wei L, Liu L. Trans-Septal Myocardial Biopsy in Hypertrophic Cardiomyopathy Using the Liwen Procedure: An Introduction of a Novel Technique. J Interv Cardiol. 2021 Feb 10;2021:1905184. doi: 10.1155/2021/1905184. eCollection 2021. |
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Improvement of LVOTG > 50% within 90 days after operation
| 90 days |
| No main adverse events related to instruments or surgery within 90 days of instrument use | 90 days |
| Life quality score of SF-36 | The life quality score of SF-36 was significantly improved after the operation. | 90 days |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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