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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM).
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
RECRUITINGMain 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.
Time frame: 30 days
Instrument success
Radiofrequency ablation system instruments reach the desired treatment site and successfully complete ablation,and remove the system successfully.
Time frame: 30 days
Operation success
Improvement of LVOTG \> 50% within 90 days after operation
Time frame: 90 days
No main adverse events related to instruments or surgery within 90 days of instrument use
Time frame: 90 days
Life quality score of SF-36
The life quality score of SF-36 was significantly improved after the operation.
Time frame: 90 days
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