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Assessmet of Patients With PAH Right Ventricular Volume

Study:

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

Rationale:

n/a

Purpose:

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 Status: Recruiting

Recruiting:
Richard Krasuski, MD krasusr@ccf.org

Condition Intervention Phase
Pulmonary Arterial Hypertension Device: Ventripoint Medical System Phase 3

Verified by VentriPoint Diagnostics Ltd. October, 2012

Sponsored by: VentriPoint Diagnostics Ltd.
Information provided by: VentriPoint Diagnostics Ltd.
ClinicalTrials.gov identifier: NCT01557582

Study Type: Interventional

Study Design: Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label

Cleveland Clinic
Cleveland, Ohio 44195
United States

Robyn Barst, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.