← Back to Search

Medical Device

Assessmet of Patients With PAH Right Ventricular Volume

N/A
Waitlist Available
Led By Robyn Barst, MD
Research Sponsored by VentriPoint Diagnostics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up vms occured on day 1 and required 15 minutes and mri occurred on day 1 and required 1 hour.
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~vms occured on day 1 and required 15 minutes and mri occurred on day 1 and required 1 hour.
This trial's timeline: 3 weeks for screening, Varies for treatment, and vms occured on day 1 and required 15 minutes and mri occurred on day 1 and required 1 hour. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Observed Mean (Std Err) for % Difference Between VMS and MRI.
Secondary study objectives
Inter-Observer Variability
Intra-Observer Variability

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ventripoint Medical System
2012
N/A
~110

Find a Location

Who is running the clinical trial?

VentriPoint Diagnostics Ltd.Lead Sponsor
1 Previous Clinical Trials
109 Total Patients Enrolled
Robyn Barst, MDPrincipal InvestigatorScientific Advisory Board
~7 spots leftby Jan 2026