The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
NCT Number: NCT04686487
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Changsha, Hunan, 410011, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
stereotactic ablative radiotherapy by targeting high energy heavy ion beams at a specific area of the body
Time frame: 3 months
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: 1, 3, 6 and 12 months
death, heart failure, myocardial infarction and stroke
Time frame: 1, 3, 6 and 12 months
diagnosis by electrocardiogram
Time frame: 1, 3, 6 and 12 months
Assessed with transthoracic echocardiography
Time frame: 1, 3, 6 and 12 months
6 minute Walk Test
Time frame: 1, 3, 6 and 12 months
Measured on echocardiography
Second Xiangya Hospital of Central South University
Other
Stereotactic Ablative Radiotherapy in Patients With Hypertrophic Obstructive Cardiomyopathy: First in Man Pilot Study
Acronym: SELECT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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