Assessmet of Patients With PAH Right Ventricular Volume

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byRobyn Barst, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VentriPoint Diagnostics Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Inclusion Criteria

Patients with Group 1 Pulmonary Arterial Hypertension

IPAH

HPAH

+6 more

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Right ventrical volumn comparisonExperimental Treatment1 Intervention

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.