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Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed. About 70% of them are hypertrophic obstructive cardiomyopathy (HOCM), these HOCM patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, percutaneous transluminal septal myocardial ablation(PTSMA), percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) and percutaneous endocardial septal radiofrequency ablation (PESA) is introduced to patients with refractory symptoms or drug resistance. However, surgical operations are complicated and high risk procedures with high mortality. Interventional approaches are very difficult to perform and therefore the application is limited.
Previous researches have shown that interventricular septal radiofrequency ablation could effectively reduce the left ventricular outflow tract pressure gradient (LVOTG), thereby treating obstructive hypertrophic cardiomyopathy (HOCM). This device is based on the same radiofrequency ablation energy principle, however, the catheter is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum, which is potentially a lower risk route of access for septal ablation than currently attempted interventional approaches.
The purpose of this study is to evaluate the safety and efficacy of percutaneous intramyocardial septal ablation catheters in the treatment of obstructive hypertrophic cardiomyopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| percutaneous intramyocardial septal radiofrequency ablation system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous intramyocardial septal radiofrequency ablation system | Device | The device is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day major adverse clinical events (MACE) | 30-day major adverse clinical events (MACE), including death, emergency surgery, severe pericardial effusion bleeding requiring pericardiocentesis or surgery, atrioventricular block, heart perforation, and surgery-related stroke. | 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Technical success rate: the radiofrequency ablation catheter reaches the required treatment site, successfully completes the ablation, and is successfully withdrawn from the body. | 30-day |
| Short Form 36 (SF-36) health survey questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310016 | China |
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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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The life quality score of SF-36 would significantly improved after the procedure. The higher scores mean a better outcome. |
| 90-day |
| Improvement of left ventricular outflow tract gradient (LVOTG) | The improvement of LVOTG at post-procedure,30 days,3 months and 6 months after procedure. If the pressure gradient is reduced, the symptom will improve. | 6 months |
| Improvement of NYHA functional classification | The improvement of NYHA functional class at post-procedure,30 days,3 months and 6 months after procedure. The lower class mean a better outcome. | 6 months |
| 6-min walk distance | The increase of 6-min walk distance at post-procedure,30 days,3 months and 6 months after procedure. | 6 months |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |