This is a Phase 3, prospective, open-label, multicenter study to assess the efficacy of NH002-enhanced echocardiography in subjects with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the left ventricular endocardial border delineation compared with unenhanced echocardiography. The study also aims to investigate the safety and tolerability of NH002.
18 years of age or older
Ability to understand and the willingness to provide written informed consent
Having or suspected of having cardiac disease
Undergone a transthoracic echo within 30 days prior to NH002 dose administration, resulting in suboptimal LVEBD, as defined by 2 or more segments of 6 segments of the ventricular border that cannot be visualized reliably in any of the standard apical 4-, 2-, and 3-chamber views during the resting non-contrast ultrasound examination
ongoing or recent acute coronary syndrome within 6 months.
uncontrolled serious ventricular arrhythmias.
decompensated or inadequately controlled congestive heart failure (New York Heart Association Class IV).
atrial fibrillation or current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise.
Trust Bio-sonics, Inc.
Lead sponsor
CMIC ASIA-PACIFIC, PTE. LTD., TAIWAN BRANCH
Collaborator