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Completed

NCT Number: NCT04686487

SterEotactic AbLative Radiotherapy in PatiEnts With HypertrophiC ObstrucTive Cardiomyopathy

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged ≥ 18 years
  • Drug-refractory symptomatic patients with HOCM
  • Willing and able to give written informed consent

Exclusion criteria

  • Enrolled in another clinical study.
  • Patient unable to tolerate lying flat for one hour
  • Pregnant Or Lactating Women
  • With other contraindications for receive stereotactic ablative radiotherapy

Treatment and study plan

Stereotactic Ablative Radiotherapy

Procedure

stereotactic ablative radiotherapy by targeting high energy heavy ion beams at a specific area of the body

Primary outcomes

  1. Safety of stereotactic ablative radiotherapy

    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.

Secondary outcomes

  1. Assessment of MACE endpoints

    Time frame: 1, 3, 6 and 12 months

    death, heart failure, myocardial infarction and stroke

  2. Development of complete heart block, atrial or ventricular arrhythmias

    Time frame: 1, 3, 6 and 12 months

    diagnosis by electrocardiogram

  3. Change in LVOT gradient

    Time frame: 1, 3, 6 and 12 months

    Assessed with transthoracic echocardiography

  4. Change in exercise capacity

    Time frame: 1, 3, 6 and 12 months

    6 minute Walk Test

  5. Change in LV wall thickness

    Time frame: 1, 3, 6 and 12 months

    Measured on echocardiography

Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Registry information

Official study title

Stereotactic Ablative Radiotherapy in Patients With Hypertrophic Obstructive Cardiomyopathy: First in Man Pilot Study

Acronym: SELECT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2020
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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