Assessmet of Patients With PAH Right Ventricular Volume

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VentriPoint Diagnostics Ltd.
ClinicalTrials.gov Identifier:
NCT01557582
First received: August 30, 2011
Last updated: June 3, 2013
Last verified: October 2012

August 30, 2011
June 3, 2013
April 2012
November 2013   (final data collection date for primary outcome measure)
The comparison of the VMS and MRI values for EDV, ESV and EF using 75 subjects [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01557582 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Assessmet of Patients With PAH Right Ventricular Volume
Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension

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.

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.

Interventional
Phase 3
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Pulmonary Arterial Hypertension
Device: 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.

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.
Intervention: Device: Ventripoint Medical System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
83
December 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
12 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01557582
2011052
No
VentriPoint Diagnostics Ltd.
VentriPoint Diagnostics Ltd.
Not Provided
Principal Investigator: Robyn Barst, MD Scientific Advisory Board
VentriPoint Diagnostics Ltd.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP