Assessmet of Patients With PAH Right Ventricular Volume
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01557582|
Recruitment Status : Completed
First Posted : March 19, 2012
Results First Posted : March 27, 2015
Last Update Posted : March 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Device: Ventripoint Medical System||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||December 2013|
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.
- 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. ]% 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. ]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. ]Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|