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This prospective, multicenter, single-arm objective performance criteria trial is designed to assess the efficacy and safety of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The primary objectives include investigating:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Endocardial Septal Radiofrequency Ablation | Procedure | Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LVOT gradiant/midventricular gradient | Change in Left ventricular outflow tract gradient pre- and post- intervention | 6 months,9 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 minute walking test | Change in 6 minute walking distance pre- and post- intervention | 6 months,9 months and 12 months |
| Change in NYHA cardiac function class | A system used to categorize the severity of heart failure based on the functional limitations of individuals. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingmin Wu | Contact | 18810488351 | wlmxt2008@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | 100037 | 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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| 6 months,9 months and 12 months |
| Change in cTnT | Cardiac biomarker | 6 months,9 months and 12 months |
| Change in cTnI | Cardiac biomarker | 6 months,9 months and 12 months |
| Change in NT-proBNP | Cardiac biomarker | 6 months,9 months and 12 months |
| Change in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a patient reported outcome instrument with minimum score = 0 and maximum score = 100 where higher score indicates better health status. There are no units to the score. The instrument utilizes a recall period of 2 weeks over which patients describe the frequency and severity of their symptoms, their physical and social limitations, and how they perceive their heart failure symptoms to affect their quality of life. quality of life | 6 months,9 months and 12 months |
| Change in Left ventricular ejection fraction (LVEF) | LVEF measured by echocardiography | 6 months,9 months and 12 months |
| Change in Left ventricular end-diastolic diameter (LVEDD) | LVEDD measured by echocardiography | 6 months,9 months and 12 months |
| Change in Left atrial diameter (LAD) | LAD measured by echocardiography | 6 months,9 months and 12 months |
| Change in Maximal wall thickness (MWT) | MWT measured by echocardiography | 6 months,9 months and 12 months |
| Change in Left ventricular mass index (LVMi) | LVMi measured by cardiac magnetic resonance | 6 months,9 months and 12 months |
| Change in Late gadolinium enhancement (LGE) | LGE measured by cardiac magnetic resonance | 6 months,9 months and 12 months |
| Change in Cardiac index (CI) | CI measured by cardiac magnetic resonance | 6 months,9 months and 12 months |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |