NCT01557582

Assessmet of Patients With PAH Right Ventricular Volume

Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: VentriPoint Diagnostics Ltd. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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 0.025 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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2012-03-19
• Last updated: 2015-03-27
• Results posted: 2015-03-27

Locations

7 sites across 2 countries: United States, Canada