Pulmonary Arterial Hypertension Clinical Trial
Official title:
Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension
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.
The objective of this study is: The comparison of the VMS and MRI values for EDV, ESV, and
EF using 75 subjects.
Secondary objectives are:
The determination of VMS inter-observer and intra-observer variability of these quantities
using 30 subjects.
;
Intervention Model: Single Group Assignment, Masking: Open Label
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