Ignite Creation Date:
2024-05-06 @ 12:22 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01557582
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2011-08-30
Brief Title:
Assessmet of Patients With PAH Right Ventricular Volume
Sponsor:
VentriPoint Diagnostics Ltd
Organization:
VentriPoint Diagnostics Ltd
Study Overview
Official Title:
Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 0025 statistical significance level for RVEDV and for RVESV with no safety concerns for the VMS procedure
Detailed Description:
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
Secondary objectives are
The determination of VMS inter-observer and intra-observer variability of these quantities using 30 subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None