Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
China100 participantsStarted 2022-11-15
Plain-language summary
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Patients who were diagnosed as nonobstructive hypertrophic cardiomyopathy, with maximal apical wall thickness ≥ 15 mm.
✓. Patients with heart function of New York Heart Association ≥ class II.
✓. Presenting with severe symptoms, e.g. angina, dyspnea, or fatigue, that were unresponsive or intolerant to pharmaceutical therapies;
✓. Kansas City Cardiomyopathy Questionnaire (KCCQ) score \< 80;
✓. Presenting with one of the following conditions: midventricular obstruction with gradient ≥ 50 mmHg; grade II or higher diastolic dysfunction; apical aneurysm; ventricular tachycardia that needed an ICD implantation; pulmonary hypertension.
✓. Patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form.
Exclusion criteria
✕. Patients who were pregnant.
✕. Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-chamber cardiac surgery.
✕. Patients who had severe heart failure with left ventricle ejection fraction \< 50%.
✕. Patients whose estimated life expectancy \< 12 months.
. peak VO2 of cardiopulmonary exercise test ≥ 90% of predicted.
✕. LVOT obstruction.
✕. Patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.