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Assessmet of Patients With PAH Right Ventricular Volume

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ClinicalTrials.gov Identifier: NCT01557582
Recruitment Status : Completed
First Posted : March 19, 2012
Results First Posted : March 27, 2015
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
VentriPoint Diagnostics Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Pulmonary Arterial Hypertension
Intervention Device: Ventripoint Medical System
Enrollment 103
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Right Ventrical Volume Comparison
Hide 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
Reason Not Completed
Protocol Violation             4
Operator error             2
Arm/Group Title Right Ventrical Volume Comparison
Hide 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 Number of Baseline Participants 101
Hide Baseline Analysis Population Description
Demographic information was not available for 2 patients. One subject failed to disclose metal in his abdomen and the other was due to user error.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
<=18 years
0
   0.0%
Between 18 and 65 years
84
  83.2%
>=65 years
17
  16.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
84
  83.2%
Male
17
  16.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants
Asian 6
African American 17
Native American/Nat. Alaska 1
Native Hawaii/Pac Island 0
White/Caucasian 65
Hispanic/Latino 12
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants
United States 84
Canada 17
WHO Functional Health Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants
Functional Class I 7
Functional Class II 46
Functional Class III 48
[1]
Measure Description:

The World Health Organization (WHO) has developed a system to help doctors determine how limited a patient is in their ability to do the activities of daily living. In general, patients with more severe PH tend to have a higher functional class.

Class I: pulmonary hypertension without resulting limitation of physical activity; Class II: slight limitation of physical activity; Class III: marked limitation of physical activity.

Etiology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants
CONNECTIVE TISSUE 39
PORTAL HYPERTENSION 2
Simple Congenital 6
Drug/Toxin 4
Idiopathic 46
HIV Infection 1
Heritable 2
Other 1
1.Primary Outcome
Title Observed Mean (Std Err) for % Difference Between VMS and MRI.
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only evaluable participants were analyzed
Arm/Group Title Right Ventrical Volume Comparison
Hide 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 Number of Participants Analyzed 75
Mean (Standard Error)
Unit of Measure: Percent difference
EDV 4.80  (1.35)
ESV 1.76  (1.51)
EF 2.03  (0.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Right Ventrical Volume Comparison
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter EDV percent difference
Estimated Value 4.80
Confidence Interval (2-Sided) 95%
2.24 to 7.56
Estimation Comments Mean percent difference and 95% CI for EDV
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Right Ventrical Volume Comparison
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ESV percent difference
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
-1.17 to 4.76
Estimation Comments Mean percent difference and 95% CI for ESV
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Right Ventrical Volume Comparison
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter EF percent difference
Estimated Value 2.03
Confidence Interval (2-Sided) 95%
0.72 to 3.33
Estimation Comments Mean percent difference and 95% CI for EF
2.Secondary Outcome
Title Inter-Observer Variability
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All evaluable subjects.
Arm/Group Title Right Ventrical Volume Comparison
Hide 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 Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: Percent difference
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
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Right Ventrical Volume Comparison
Hide 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 Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Percent difference
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)
Time Frame Adverse events were only collected during imaging.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Right Ventrical Volume Comparison
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Right Ventrical Volume Comparison
Affected / at Risk (%)
Total   0/103 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Right Ventrical Volume Comparison
Affected / at Risk (%)
Total   0/103 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jim bodtke, Vice President Clinical Affairs and Development
Organization: VentriPoint, Inc.
Phone: 206-283-0221
Responsible Party: VentriPoint Diagnostics Ltd.
ClinicalTrials.gov Identifier: NCT01557582     History of Changes
Other Study ID Numbers: 2011052
First Submitted: August 30, 2011
First Posted: March 19, 2012
Results First Submitted: March 25, 2015
Results First Posted: March 27, 2015
Last Update Posted: March 27, 2015