Assessmet of Patients With PAH Right Ventricular Volume
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Device: Ventripoint Medical System
- Registration Number
- NCT01557582
- Lead Sponsor
- VentriPoint Diagnostics Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- 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
- 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 ห 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis
- Clinically significant cardiac ischemic disease
- Systemic hypertension defined as SBP ห 160 mmHg and/or DBP ห 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Right ventrical volumn comparison Ventripoint Medical System 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Inter-Observer Variability VMS 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 Variability VMS 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)
Trial Locations
- Locations (7)
Allegheny General Hospital
๐บ๐ธPittsburgh, Pennsylvania, United States
Toronto General Hospital
๐จ๐ฆTononto, Ontario, Canada
Baylor
๐บ๐ธHouston, Texas, United States
Brigham and Women's Hospital
๐บ๐ธBoston, Massachusetts, United States
University of Chicago
๐บ๐ธChicago, Illinois, United States
Cleveland Clinic
๐บ๐ธCleveland, Ohio, United States
Mayo Clinic
๐บ๐ธRochester, Minnesota, United States