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Assessmet of Patients With PAH Right Ventricular Volume

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557582
First Posted: March 19, 2012
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VentriPoint Diagnostics Ltd.
  Purpose
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.

Condition Intervention
Pulmonary Arterial Hypertension Device: Ventripoint Medical System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by VentriPoint Diagnostics Ltd.:

Primary Outcome Measures:
  • Observed Mean (Std Err) for % Difference Between VMS and MRI. [ Time Frame: 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:
  • Inter-Observer Variability [ Time Frame: 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 [ Time Frame: 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)


Enrollment: 103
Study Start Date: April 2012
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557582


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Baylor
Houston, Texas, United States, 77030
Canada, Ontario
Toronto General Hospital
Tononto, Ontario, Canada, M5G-2C4
Sponsors and Collaborators
VentriPoint Diagnostics Ltd.
Investigators
Principal Investigator: Robyn Barst, MD Scientific Advisory Board
  More Information

Responsible Party: VentriPoint Diagnostics Ltd.
ClinicalTrials.gov Identifier: NCT01557582     History of Changes
Other Study ID Numbers: 2011052
First Submitted: August 30, 2011
First Posted: March 19, 2012
Results First Submitted: March 25, 2015
Results First Posted: March 27, 2015
Last Update Posted: March 27, 2015
Last Verified: October 2012

Keywords provided by VentriPoint Diagnostics Ltd.:
IPAH
HPAH
APAH CTD
APAH HIV
APAH PoPH
APAH Drugs/Toxins
APAH CHD repaired
APAH CHD unrepaired

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases