Assessmet of Patients With PAH Right Ventricular Volume

• Sponsor: VentriPoint Diagnostics Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01557582
• Collaborator: (none)
• Enrollment: 103
• Locations: 7
• Arm: 1
• Duration (Months): 20
• Patients Per Site: 14.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Device: Ventripoint Medical System	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: N/A
• 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
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

1. Observed Mean (Std Err) for % Difference Between VMS and MRI. [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

1. Inter-Observer Variability [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.

2. Intra-Observer Variability [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637
2	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
3	Mayo Clinic	Rochester	Minnesota	United States	55905
4	Cleveland Clinic	Cleveland	Ohio	United States	44195
5	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
6	Baylor	Houston	Texas	United States	77030
7	Toronto General Hospital	Tononto	Ontario	Canada	M5G-2C4

Sponsors and Collaborators

• VentriPoint Diagnostics Ltd.

Investigators

• Principal Investigator: Robyn Barst, MD, Scientific Advisory Board

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VentriPoint Diagnostics Ltd.
• ClinicalTrials.gov Identifier: NCT01557582
• Other Study ID Numbers: 2011052
• First Posted: Mar 19, 2012
• Last Update Posted: Mar 27, 2015
• Last Verified: Oct 1, 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: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension

Study Results

Participant Flow

Arm/Group Title	Right Ventrical Volume Comparison
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	103
COMPLETED	97
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Right Ventrical Volume Comparison
Arm/Group Description	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. 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.
Overall Participants	101
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	84 83.2%
>=65 years	17 16.8%
Sex: Female, Male (Count of Participants)
Female	84 83.2%
Male	17 16.8%
Race/Ethnicity, Customized (participants) [Number]
Asian	6 5.9%
African American	17 16.8%
Native American/Nat. Alaska	1 1%
Native Hawaii/Pac Island	0 0%
White/Caucasian	65 64.4%
Hispanic/Latino	12 11.9%
Region of Enrollment (participants) [Number]
United States	84 83.2%
Canada	17 16.8%
WHO Functional Health Class (participants) [Number]
Functional Class I	7 6.9%
Functional Class II	46 45.5%
Functional Class III	48 47.5%
Etiology (participants) [Number]
CONNECTIVE TISSUE	39 38.6%
PORTAL HYPERTENSION	2 2%
Simple Congenital	6 5.9%
Drug/Toxin	4 4%
Idiopathic	46 45.5%
HIV Infection	1 1%
Heritable	2 2%
Other	1 1%

Outcome Measures

1. Primary Outcome

Title	Observed Mean (Std Err) for % Difference Between VMS and MRI.
Description	% Difference was measured for right ventricular EDV, ESV and EF.
Time Frame	VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.

Outcome Measure Data

Analysis Population Description

Only evaluable participants were analyzed

Arm/Group Title	Right Ventrical Volume Comparison
Arm/Group Description	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. 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.
Measure Participants	75
EDV	4.80 (1.35)
ESV	1.76 (1.51)
EF	2.03 (0.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Right Ventrical Volume Comparison
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	EDV percent difference
	Estimated Value	4.80
	Confidence Interval	(2-Sided) 95%; 2.24 to 7.56
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean percent difference and 95% CI for EDV

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Right Ventrical Volume Comparison
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	ESV percent difference
	Estimated Value	1.76
	Confidence Interval	(2-Sided) 95%; -1.17 to 4.76
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean percent difference and 95% CI for ESV

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Right Ventrical Volume Comparison
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	EF percent difference
	Estimated Value	2.03
	Confidence Interval	(2-Sided) 95%; 0.72 to 3.33
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean percent difference and 95% CI for EF

2. Secondary Outcome

Title	Inter-Observer Variability
Description	A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.
Time Frame	VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.

Outcome Measure Data

Analysis Population Description

All evaluable subjects.

Arm/Group Title	Right Ventrical Volume Comparison
Arm/Group Description	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. 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.
Measure Participants	75
EDV Observer 2 vs. 1	12.99 (10.59)
EDV Observer 3 vs. 1	18.41 (16.45)
EDV Observer 3 vs. 2	18.49 (15.05)
ESV Observer 2 vs. 1	10.13 (8.60)
ESV Observer 3 vs. 1	15.10 (13.90)
ESV Observer 3 vs. 2	14.38 (12.53)
EF Observer 2 vs. 1	5.83 (4.51)
EF Observer 3 vs. 1	6.12 (5.46)
EF Observer 3 vs. 2	6.83 (5.33)

3. Secondary Outcome

Title	Intra-Observer Variability
Description	Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)
Time Frame	VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Right Ventrical Volume Comparison
Arm/Group Description	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. 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.
Measure Participants	35
EDV Observer 1	1.41 (6.40)
EDV Observer 2	2.43 (11.92)
EDV Observer 3	3.48 (20.51)
ESV Observer 1	4.01 (4.99)
ESV Observer 2	1.66 (10.32)
ESV Observer 3	10.72 (20.38)
EF Observer 1	-1.33 (2.00)
EF Observer 2	0.15 (4.49)
EF Observer 3	-3.02 (8.81)

Adverse Events

Time Frame	Adverse events were only collected during imaging.
Arm/Group Title	Right Ventrical Volume Comparison
Arm/Group Description	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. 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.
All Cause Mortality
	Right Ventrical Volume Comparison
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Right Ventrical Volume Comparison
	Affected / at Risk (%)	# Events
Total	0/103 (0%)
Other (Not Including Serious) Adverse Events
	Right Ventrical Volume Comparison
	Affected / at Risk (%)	# Events
Total	0/103 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.