Assessmet of Patients With PAH Right Ventricular Volume

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557582
• Other study ID #: 2011052
• Status: Completed
• Phase: N/A
• First received: August 30, 2011
• Last updated: March 25, 2015
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2012
• Source: VentriPoint Diagnostics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Tononto	Ontario
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Baylor	Houston	Texas
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VentriPoint Diagnostics Ltd.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No