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Assessmet of Patients With PAH Right Ventricular Volume

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01557582
Enrollment
103
Registered
2012-03-19
Start date
2012-04-30
Completion date
2013-12-31
Last updated
2015-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

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

Brief 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.

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.

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.

Sponsors

VentriPoint Diagnostics Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Observed Mean (Std Err) for % Difference Between VMS and MRI.VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.% Difference was measured for right ventricular EDV, ESV and EF.

Secondary

MeasureTime frameDescription
Inter-Observer VariabilityVMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.
Intra-Observer VariabilityVMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)

Countries

Canada, United States

Participant flow

Participants by arm

ArmCount
Right Ventrical Volume 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. 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.
101
Total101

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyOperator error2
Overall StudyProtocol Violation4

Baseline characteristics

CharacteristicRight Ventrical Volume Comparison
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
17 Participants
Age, Categorical
Between 18 and 65 years
84 Participants
Etiology
CONNECTIVE TISSUE
39 participants
Etiology
Drug/Toxin
4 participants
Etiology
Heritable
2 participants
Etiology
HIV Infection
1 participants
Etiology
Idiopathic
46 participants
Etiology
Other
1 participants
Etiology
PORTAL HYPERTENSION
2 participants
Etiology
Simple Congenital
6 participants
Race/Ethnicity, Customized
African American
17 participants
Race/Ethnicity, Customized
Asian
6 participants
Race/Ethnicity, Customized
Hispanic/Latino
12 participants
Race/Ethnicity, Customized
Native American/Nat. Alaska
1 participants
Race/Ethnicity, Customized
Native Hawaii/Pac Island
0 participants
Race/Ethnicity, Customized
White/Caucasian
65 participants
Region of Enrollment
Canada
17 participants
Region of Enrollment
United States
84 participants
Sex: Female, Male
Female
84 Participants
Sex: Female, Male
Male
17 Participants
WHO Functional Health Class
Functional Class I
7 participants
WHO Functional Health Class
Functional Class II
46 participants
WHO Functional Health Class
Functional Class III
48 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 103
serious
Total, serious adverse events
0 / 103

Outcome results

Primary

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.

Population: Only evaluable participants were analyzed

ArmMeasureGroupValue (MEAN)Dispersion
Right Ventrical Volume ComparisonObserved Mean (Std Err) for % Difference Between VMS and MRI.EDV4.80 Percent differenceStandard Error 1.35
Right Ventrical Volume ComparisonObserved Mean (Std Err) for % Difference Between VMS and MRI.ESV1.76 Percent differenceStandard Error 1.51
Right Ventrical Volume ComparisonObserved Mean (Std Err) for % Difference Between VMS and MRI.EF2.03 Percent differenceStandard Error 0.66
95% CI: [2.24, 7.56]
95% CI: [-1.17, 4.76]
95% CI: [0.72, 3.33]
Secondary

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.

Population: All evaluable subjects.

ArmMeasureGroupValue (MEAN)Dispersion
Right Ventrical Volume ComparisonInter-Observer VariabilityEDV Observer 2 vs. 112.99 Percent differenceStandard Deviation 10.59
Right Ventrical Volume ComparisonInter-Observer VariabilityEDV Observer 3 vs. 118.41 Percent differenceStandard Deviation 16.45
Right Ventrical Volume ComparisonInter-Observer VariabilityEDV Observer 3 vs. 218.49 Percent differenceStandard Deviation 15.05
Right Ventrical Volume ComparisonInter-Observer VariabilityESV Observer 2 vs. 110.13 Percent differenceStandard Deviation 8.6
Right Ventrical Volume ComparisonInter-Observer VariabilityESV Observer 3 vs. 115.10 Percent differenceStandard Deviation 13.9
Right Ventrical Volume ComparisonInter-Observer VariabilityESV Observer 3 vs. 214.38 Percent differenceStandard Deviation 12.53
Right Ventrical Volume ComparisonInter-Observer VariabilityEF Observer 2 vs. 15.83 Percent differenceStandard Deviation 4.51
Right Ventrical Volume ComparisonInter-Observer VariabilityEF Observer 3 vs. 16.12 Percent differenceStandard Deviation 5.46
Right Ventrical Volume ComparisonInter-Observer VariabilityEF Observer 3 vs. 26.83 Percent differenceStandard Deviation 5.33
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Right Ventrical Volume ComparisonIntra-Observer VariabilityEDV Observer 11.41 Percent differenceStandard Deviation 6.4
Right Ventrical Volume ComparisonIntra-Observer VariabilityEDV Observer 22.43 Percent differenceStandard Deviation 11.92
Right Ventrical Volume ComparisonIntra-Observer VariabilityEDV Observer 33.48 Percent differenceStandard Deviation 20.51
Right Ventrical Volume ComparisonIntra-Observer VariabilityESV Observer 14.01 Percent differenceStandard Deviation 4.99
Right Ventrical Volume ComparisonIntra-Observer VariabilityESV Observer 21.66 Percent differenceStandard Deviation 10.32
Right Ventrical Volume ComparisonIntra-Observer VariabilityESV Observer 310.72 Percent differenceStandard Deviation 20.38
Right Ventrical Volume ComparisonIntra-Observer VariabilityEF Observer 1-1.33 Percent differenceStandard Deviation 2
Right Ventrical Volume ComparisonIntra-Observer VariabilityEF Observer 20.15 Percent differenceStandard Deviation 4.49
Right Ventrical Volume ComparisonIntra-Observer VariabilityEF Observer 3-3.02 Percent differenceStandard Deviation 8.81

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026