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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
stereotactic ablative radiotherapy by targeting high energy heavy ion beams at a specific area of the body
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
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.
Time frame: 3 months
Assessment of MACE endpoints
death, heart failure, myocardial infarction and stroke
Time frame: 1, 3, 6 and 12 months
Development of complete heart block, atrial or ventricular arrhythmias
diagnosis by electrocardiogram
Time frame: 1, 3, 6 and 12 months
Change in LVOT gradient
Assessed with transthoracic echocardiography
Time frame: 1, 3, 6 and 12 months
Change in exercise capacity
6 minute Walk Test
Time frame: 1, 3, 6 and 12 months
Change in LV wall thickness
Measured on echocardiography
Time frame: 1, 3, 6 and 12 months
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