Assessmet of Patients With PAH Right Ventricular Volume
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 Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension|
- Observed Mean (Std Err) for % Difference Between VMS and MRI. [ Time Frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. ] [ Designated as safety issue: No ]% Difference was measured for right ventricular EDV, ESV and EF.
- Inter-Observer Variability [ Time Frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. ] [ Designated as safety issue: No ]A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.
- Intra-Observer Variability [ Time Frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. ] [ Designated as safety issue: No ]Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)
|Study Start Date:||April 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Right ventrical volumn comparison
Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Device: Ventripoint Medical System
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557582
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15212|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Toronto General Hospital|
|Tononto, Ontario, Canada, M5G-2C4|
|Principal Investigator:||Robyn Barst, MD||Scientific Advisory Board|