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CompletedNCT01557582Updated Mar 27, 2015Results posted

Assessmet of Patients With PAH Right Ventricular Volume

An interventional study of Ventripoint Medical System in Pulmonary Arterial Hypertension, sponsored by VentriPoint Diagnostics Ltd.. Completed at 7 sites in 2 countries. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-27.

Sponsored by VentriPoint Diagnostics Ltd. · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • IPAH
  • HPAH
  • APAH CTD
  • APAH HIV
  • APAH PoPH
  • APAH Drugs/Toxins
  • APAH CHD repaired
  • APAH CHD unrepaired
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 103 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

VentriPoint Diagnostics Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with Group 1 Pulmonary Arterial Hypertension
  • IPAH
  • HPAH
  • APAH-CTD
  • APAH-HIV
  • APAH-PoPH
  • APAH-Drugs/Toxins
  • APAH-CHD repaired simple systemic to pulmonary shunts, i.e. ASD, VSD and/or PDA
  • APAH-CHD unrepaired simple systemic to pulmonary shunts, i.e. ASD, VSD and/or PDA Patients who can be expected to lie motionless during imagine Males and females 12 years of age and older

Exclusion criteria

Exclusion Criteria:

  • Lack of informed consent (and assent as appropriate)
  • Other forms of PH not included in inclusion criteria
  • Left heart disease including clinically significant valvular disease, ,i.e. moderate or greater mitral regurgitation or stenosis or mild or greater aortic insufficiency or stenosis, pericardial disease, LV systolic dysfunction, i.e. LVEF \<40% or LVSF \<22%, and/or clinically significant LVDD
  • Known/detected arrhythmia that interferes with image acquisition
  • Implanted cardiac defibrillator, pacemaker, or other devices containing ferromagnetic materials
  • Pregnant or breast-feeding females
  • Contraindications for MRI (for those patient that undergo MRI)
  • Clinically significant obstructive or restrictive lung disease
  • Subjects with known HIV infection who have any clinical or laboratory evidence of any opportunistic pulmonary disease (e.g., tuberculosis, Pneumocystis carinii pneumonia, or other pneumonias)
  • PAH associated with thyroid disorders, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy
  • Any subjects with congenital heart disease other than the simple congenital to systemic shunts specified in the inclusion criteria
  • PAH associated with significant venous or capillary involvement (PCWP ˃ 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis
  • Clinically significant cardiac ischemic disease
  • Systemic hypertension defined as SBP ˃ 160 mmHg and/or DBP ˃ 95 mmHg (treated or untreated)
  • Moderate or severe hepatic impairment, i.e., Child-Pugh Class B or C
  • Any subject with obstructive sleep apnea or who requires the use of CPAP or BiPAP device
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Other
    Right ventrical volumn comparison

    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.

    Device: Ventripoint Medical System

Interventions

  • DeviceVentripoint 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.

06

What researchers measure

Primary outcomes

  1. Observed Mean (Std Err) for % Difference Between VMS and MRI.

    % Difference was measured for right ventricular EDV, ESV and EF.

    Time frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.

Secondary outcomes

  1. Inter-Observer Variability

    A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.

    Time frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.

  2. Intra-Observer Variability

    Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)

    Time frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.

07

Results

Posted Mar 27, 2015

Participant flow

Participant flow — Overall Study
MilestoneRight Ventrical Volume Comparison
Started103
Completed97
Not completed6
Withdrew: Protocol violation4
Withdrew: Operator error2

Outcome measures

PrimaryObserved Mean (Std Err) for % Difference Between VMS and MRI.

% Difference was measured for right ventricular EDV, ESV and EF.

Time frame:
VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Reported as:
Mean · Percent difference
Observed Mean (Std Err) for % Difference Between VMS and MRI.
Percent differenceRight Ventrical Volume Comparison
EDV4.80 ± 1.35
ESV1.76 ± 1.51
EF2.03 ± 0.66
Statistical analysis
  • Right Ventrical Volume Comparison · Edv percent difference: 4.80 · 95% CI 2.24 to 7.56Mean percent difference and 95% CI for EDV
  • Right Ventrical Volume Comparison · Esv percent difference: 1.76 · 95% CI -1.17 to 4.76Mean percent difference and 95% CI for ESV
  • Right Ventrical Volume Comparison · Ef percent difference: 2.03 · 95% CI 0.72 to 3.33Mean percent difference and 95% CI for EF
SecondaryInter-Observer Variability

A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.

Time frame:
VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Reported as:
Mean · Percent difference
Inter-Observer Variability
Percent differenceRight Ventrical Volume Comparison
EDV Observer 2 vs. 112.99 ± 10.59
EDV Observer 3 vs. 118.41 ± 16.45
EDV Observer 3 vs. 218.49 ± 15.05
ESV Observer 2 vs. 110.13 ± 8.60
ESV Observer 3 vs. 115.10 ± 13.90
ESV Observer 3 vs. 214.38 ± 12.53
EF Observer 2 vs. 15.83 ± 4.51
EF Observer 3 vs. 16.12 ± 5.46
EF Observer 3 vs. 26.83 ± 5.33
SecondaryIntra-Observer Variability

Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)

Time frame:
VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Reported as:
Mean · Percent difference
Intra-Observer Variability
Percent differenceRight Ventrical Volume Comparison
EDV Observer 11.41 ± 6.40
EDV Observer 22.43 ± 11.92
EDV Observer 33.48 ± 20.51
ESV Observer 14.01 ± 4.99
ESV Observer 21.66 ± 10.32
ESV Observer 310.72 ± 20.38
EF Observer 1-1.33 ± 2.00
EF Observer 20.15 ± 4.49
EF Observer 3-3.02 ± 8.81

Adverse events

Collected over Adverse events were only collected during imaging.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Right Ventrical Volume Comparison—0/103 (0%)0/103 (0%)

Baseline characteristics

Demographic information was not available for 2 patients. One subject failed to disclose metal in his abdomen and the other was due to user error.

Age, Categorical
Age, Categorical(Participants)Right Ventrical Volume Comparison
<=18 years0
Between 18 and 65 years84
>=65 years17
Sex: Female, Male
Sex: Female, Male(Participants)Right Ventrical Volume Comparison
Female84
Male17
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Right Ventrical Volume Comparison
Asian6
African American17
Native American/Nat. Alaska1
Native Hawaii/Pac Island0
White/Caucasian65
Hispanic/Latino12
Region of Enrollment
Region of Enrollment(participants)Right Ventrical Volume Comparison
United States84
Canada17
WHO Functional Health Class
WHO Functional Health Class(participants)Right Ventrical Volume Comparison
Functional Class I7
Functional Class II46
Functional Class III48
Etiology
Etiology(participants)Right Ventrical Volume Comparison
CONNECTIVE TISSUE39
PORTAL HYPERTENSION2
Simple Congenital6
Drug/Toxin4
Idiopathic46
HIV Infection1
Heritable2
Other1
08

Study locations

7 sites
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
  • Baylor
    Houston, Texas 77030, United States
  • Toronto General Hospital
    Tononto, Ontario M5G-2C4, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01557582
Lead sponsor
VentriPoint Diagnostics Ltd.
Responsible party
Sponsor
First posted
Mar 19, 2012
Start date
Apr 2012
Primary completion
Nov 2013
Completion
Dec 2013
Results posted
Mar 27, 2015
Last update
Mar 27, 2015

Study contacts

Robyn Barst, MD
principal investigator · Scientific Advisory Board

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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