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
  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 Phase
Pulmonary Arterial Hypertension
Device: Ventripoint Medical System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: 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:
  • 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 ]

Estimated Enrollment: 83
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated 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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: VentriPoint Diagnostics Ltd.
ClinicalTrials.gov Identifier: NCT01557582     History of Changes
Other Study ID Numbers: 2011052
Study First Received: August 30, 2011
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

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, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014