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Hypertrophic obstructive cardiomyopathy (HOCM) is an inherited myocardial disease which leads to the muscle in the wall of the heart growing and thickening to the point that it blocks blood flow exiting the heart with increasing risk of sudden cardiac death, heart failure, and atrial fibrillation. Surgical septal myectomy and alcohol septal ablation are two invasive therapies for drug-refractory symptomatic patients with HOCM. Unfortunately, some patients may be unsuitable for both the two procedures. Recently, stereotactic ablative radiotherapy, usually used for the treatment of tumours, was confirmed to be feasible, safe and effective in destroying abnormal tissue in heart by targeting high energy heavy ion beams at a specific area of the body precisely. In this study we will determine whether radiation ablation, can be used to destroy the thick heart muscle at the point of obstruction safely and effectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Ablative Radiotherapy | Other | Stereotactic body radiation therapy delivered to the thick heart muscle at the point of obstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic ablative radiotherapy | Procedure | stereotactic ablative radiotherapy by targeting high energy heavy ion beams at a specific area of the body |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of stereotactic ablative radiotherapy | The primary safety endpoint is defined as serious adverse events (SAEs) that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive alcohol septal-ablation procedures. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of MACE endpoints | death, heart failure, myocardial infarction and stroke | 1, 3, 6 and 12 months |
| Development of complete heart block, atrial or ventricular arrhythmias | diagnosis by electrocardiogram |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37503357 | Derived | Li X, Zhu Z, Liu J, Gao Y, Xiao Y, Fang Z, Liu Q, Liu X, Hu C, Ma F, Zeng M, Liu Z, Hu L, Liu N, Xiang F, Hu X, Huang L, Zhou S. Septal radioablation therapy for patients with hypertrophic obstructive cardiomyopathy: first-in-human study. Eur Heart J Open. 2023 May 23;3(3):oead052. doi: 10.1093/ehjopen/oead052. eCollection 2023 May. |
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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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| 1, 3, 6 and 12 months |
| Change in LVOT gradient | Assessed with transthoracic echocardiography | 1, 3, 6 and 12 months |
| Change in exercise capacity | 6 minute Walk Test | 1, 3, 6 and 12 months |
| Change in LV wall thickness | Measured on echocardiography | 1, 3, 6 and 12 months |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |