Assessmet of Patients With PAH Right Ventricular Volume

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Device: Ventripoint Medical System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Right ventrical volumn comparison<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed Mean (Std Err) for % Difference Between VMS and MRI. | % Difference was measured for right ventricular EDV, ESV and EF. | VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-Observer Variability | A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies. | VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. | 
| Intra-Observer Variability | Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1) | VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IPAH, HPAH, APAH CTD, APAH HIV, APAH PoPH, APAH Drugs/Toxins, APAH CHD repaired, APAH CHD unrepaired