Assessmet of Patients With PAH Right Ventricular Volume

NCT01557582 | Completed Results

• 1 other identifier: 2011052
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 7

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

IPAH; HPAH; APAH CTD; APAH HIV; APAH PoPH; APAH Drugs/Toxins; APAH CHD repaired; APAH CHD unrepaired

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Inter-Observer Variability

  VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.

• Intra-Observer Variability

  VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.

Study Arms (1)

Right ventrical volumn comparison

OTHER

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

Interventions

Ventripoint Medical System 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.

Right ventrical volumn comparison

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lack of informed consent (and assent as appropriate)
• 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

Sponsors & Collaborators

• VentriPoint Diagnostics Ltd.: lead

Study Sites (7)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Baylor

Houston, Texas, 77030, United States

Location

Toronto General Hospital

Tononto, Ontario, M5G-2C4, Canada

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Jim bodtke, Vice President Clinical Affairs and Development
• Organization: VentriPoint, Inc.

jbodtke@ventripoint.com

206-283-0221

Study Officials

• Robyn Barst, MD

  Scientific Advisory Board

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: March 19, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 27, 2015
• Results First Posted: March 27, 2015

Record last verified: 2012-10

Locations

US (6); CA (1)