N/A
N=103
Assessmet of Patients With PAH Right Ventricular Volume
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01557582 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Observed Mean (Std Err) for % Difference Between VMS and MRI. — 4.80; 1.76; 2.03 Percent difference
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ventripoint Medical System (Device)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- VentriPoint Diagnostics Ltd.
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observed Mean (Std Err) for % Difference Between VMS and MRI. |
4.80; 1.76; 2.03 | — |
| SECONDARY Inter-Observer Variability |
12.99; 18.41; 18.49; 10.13; 15.10; 14.38 | — |
| SECONDARY Intra-Observer Variability |
1.41; 2.43; 3.48; 4.01; 1.66; 10.72 | — |
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% at a 1-sided 0.025 statistical significance level for RVEDV and for RVESV, with no safety concerns for the VMS procedure.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01557582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.