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Assessmet of Patients With PAH Right Ventricular Volume

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VentriPoint Diagnostics Ltd.
ClinicalTrials.gov Identifier:
NCT01557582
First received: August 30, 2011
Last updated: March 25, 2015
Last verified: October 2012
Results First Received: March 25, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Pulmonary Arterial Hypertension
Intervention: Device: Ventripoint Medical System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Right Ventrical Volume 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.

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.


Participant Flow:   Overall Study
    Right Ventrical Volume Comparison
STARTED   103 
COMPLETED   97 
NOT COMPLETED   6 
Protocol Violation                4 
Operator error                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Right Ventrical Volume 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.

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.


Baseline Measures
   Right Ventrical Volume Comparison 
Overall Participants Analyzed 
[Units: Participants]
 101 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   84 
>=65 years   17 
Gender 
[Units: Participants]
 
Female   84 
Male   17 
Race/Ethnicity, Customized 
[Units: 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 
[Units: Participants]
 
United States   84 
Canada   17 
WHO Functional Health Class [1] 
[Units: Participants]
 
Functional Class I   7 
Functional Class II   46 
Functional Class III   48 
[1]

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 
[Units: Participants]
 
CONNECTIVE TISSUE   39 
PORTAL HYPERTENSION   2 
Simple Congenital   6 
Drug/Toxin   4 
Idiopathic   46 
HIV Infection   1 
Heritable   2 
Other   1 


  Outcome Measures
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1.  Primary:   Observed Mean (Std Err) for % Difference Between VMS and MRI.   [ Time Frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. ]

2.  Secondary:   Inter-Observer Variability   [ Time Frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. ]

3.  Secondary:   Intra-Observer Variability   [ Time Frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: jbodtke@ventripoint.com



Responsible Party: VentriPoint Diagnostics Ltd.
ClinicalTrials.gov Identifier: NCT01557582     History of Changes
Other Study ID Numbers: 2011052
Study First Received: August 30, 2011
Results First Received: March 25, 2015
Last Updated: March 25, 2015
Health Authority: United States: Food and Drug Administration