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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Device: Ventripoint Medical System

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Tononto, Ontario, Canada, M5G-2C4
      • Toronto General Hospital
• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: VentriPoint Diagnostics Ltd.
• Investigators: Principal Investigator: Robyn Barst, MD, Scientific Advisory Board

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: March 16, 2012
• First Posted (Estimate): March 19, 2012

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: IPAH; HPAH; APAH CTD; APAH HIV; APAH PoPH; APAH Drugs/Toxins; APAH CHD repaired; APAH CHD unrepaired
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: 2011052