At a glance
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Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension
In Brief
A clinical study evaluating Ventripoint Medical System for Pulmonary Arterial Hypertension. Completed, enrolled 103 participants across 7 sites in 2 countries.
Detailed Summary
The primary endpoint of this study is the percent difference between the VentriPoint Medical System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular volumes (RVEDV and RVESV) in subjects with Pulmonary Arterial Hypertension (PAH). The trial will be defined as positive if the mean VMS-cMRI percent difference is \<10% and \>-10% at a 1-sided 0.025 statistical significance level for RVEDV and for RVESV, with no safety concerns for the VMS procedure.
Study Details
Timeline
Interventions
The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required. Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images.