Assessmet of Patients With PAH Right Ventricular Volume

NCT ID: NCT01557582

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-12-31

Brief 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% and >-10% at a 1-sided 0.025 statistical significance level for RVEDV and for RVESV, with no safety concerns for the VMS procedure.

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Ventripoint Medical System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• 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
• 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

Exclusion Criteria

• Lack of informed consent (and assent as appropriate)

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VentriPoint Diagnostics Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robyn Barst, MD

Role: PRINCIPAL_INVESTIGATOR

Scientific Advisory Board

Locations

University of Chicago

Chicago, Illinois, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Cleveland Clinic

Cleveland, Ohio, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Baylor

Houston, Texas, United States

Toronto General Hospital

Tononto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

2011052

Identifier Type: -

Identifier Source: org_study_id