This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM).
Participants were randomized into two groups:
At least 18 years old at screening.
Body weight was greater than 45 kg at screening.
Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Chinese Society of Cardiology guidelines, ie, satisfy criteria below (criteria to be documented by the echocardiography core laboratory): A. Had unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥15 mm (or ≥13 mm with positive family history of hypertrophic cardiomyopathy), as determined by core laboratory interpretation, and B. Had left ventricular outflow tract (LVOT) peak gradient ≥50 mm Hg during screening as assessed by echocardiography at rest or after Valsalva maneuver (confirmed by echocardiography core laboratory interpretation).
Had documented LV ejection fraction (LVEF) ≥55% by echocardiography core laboratory read of screening TTE at rest.
1) Participated in a clinical trial in which the participant received any investigational drug (or was currently using an investigational device) within 30 days prior to screening, or at least 5 times the respective elimination half-life (if known), whichever was longer.