Pulmonary Arterial HypertensionNCT01557582
Assessmet of Patients With PAH Right Ventricular Volume
A study testing Ventripoint Medical System in people with Pulmonary Arterial Hypertension, run by VentriPoint Diagnostics Ltd. at 7 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Ventripoint Medical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Apr 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with Group 1 Pulmonary Arterial Hypertension
- IPAH
- HPAH
- APAH-CTD
- APAH-HIV
- APAH-PoPH
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- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor
Houston, Texas, 77030
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension
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.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Ventripoint Medical System
- Keywords
- IPAH, HPAH, APAH CTD, APAH HIV, APAH PoPH, APAH Drugs/Toxins, APAH CHD repaired, APAH CHD unrepaired
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventripoint Medical SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ventripoint Medical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Mean (Std Err) for % Difference Between VMS and MRI.
% Difference was measured for right ventricular EDV, ESV and EF.
Measured: 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
A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.
Measured: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Intra-Observer Variability
Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)
Measured: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- VentriPoint Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robyn Barst, MD, Principal investigator, Scientific Advisory Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557582
- Sponsor's protocol ID
- 2011052
- Status last verified
- Oct 2012
- First submitted
- 30 Aug 2011
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01557582
- Acronym / sponsor ID
- 2011052
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- IPAH, HPAH, APAH CTD, APAH HIV, APAH PoPH, APAH Drugs/Toxins, APAH CHD repaired, APAH CHD unrepaired
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- VentriPoint Diagnostics Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Mar 2012 (estimated)
- Results
- Posted 27 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Right ventrical volumn comparison | Other | Device: Ventripoint Medical SystemSingle 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with Group 1 Pulmonary Arterial Hypertension
- IPAH
- HPAH
- APAH-CTD
- APAH-HIV
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventripoint Medical SystemThe 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. | Device | Right ventrical volumn comparison |
Primary outcome
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.
% Difference was measured for right ventricular EDV, ESV and EF.
2 secondary outcomes
Inter-Observer Variability
Time frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Intra-Observer Variability
Time frame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn Barst, MD principal investigator
Scientific Advisory Board
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventripoint Medical System in people with Pulmonary Arterial Hypertension, run by VentriPoint Diagnostics Ltd. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.