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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
103
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.
University of Chicago
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Observed Mean (Std Err) for % Difference Between VMS and MRI.
% Difference was measured for right ventricular EDV, ESV and EF.
Time frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Inter-Observer Variability
A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.
Time frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Intra-Observer Variability
Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)
Time frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
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Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Baylor
Houston, Texas, United States
Toronto General Hospital
Tononto, Ontario, Canada