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Assessmet of Patients With PAH Right Ventricular Volume

NCT01557582 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2015-03-27

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • VentriPoint Diagnostics Ltd.

    lead INDUSTRY

Principal Investigators

  • Robyn Barst, MD · Scientific Advisory Board

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01557582 on ClinicalTrials.gov