This is a phase III, prospective, multicenter, open-label, crossover study of the safety and efficacy of NH002-enhanced echocardiography in adult subjects with suboptimal images on non-contrast 2D transthoracic echocardiography with harmonic imaging within 30 days ahead of NH002 administration. The efficacy for two different modes of administration (i.e., IV bolus injection and infusion) will be evaluated independently.
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
Syneos Health
Collaborator