Assessmet of Patients With PAH Right Ventricular Volume
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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 | Intervention | Phase |
---|---|---|
Pulmonary Arterial Hypertension |
Device: Ventripoint Medical System |
Phase 3 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Bio-equivalence Study Intervention Model: Single Group Assignment Masking: Open Label |
Official Title: | Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension |
- The comparison of the VMS and MRI values for EDV, ESV and EF using 75 subjects [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Estimated Enrollment: | 83 |
Study Start Date: | April 2012 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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. |
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.
![](https://webarchive.library.unt.edu/web/20130305102926im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
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
![](https://webarchive.library.unt.edu/web/20130305102926im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Mardi Gomberg, MD mgomberg@medicine.bsd.uchicago.edu | |
Principal Investigator: Mardi Gomberg, MD | |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Aaron Waxman, MD PhD 617-525-9733 abwaxman@partners.org | |
Contact: Laurie Lawler, RN 617-525-9731 llawler@partners.org | |
Principal Investigator: Aaron Waxman, MD | |
Sub-Investigator: Mike Landzberg, MD | |
Sub-Investigator: Sasha Opotowsky, MD | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Robert Frantz, MD frantz.robert@mayo.edu | |
Contact: Jill Boyum 507-266-3180 boyum.jill@mayo.edu | |
Principal Investigator: Robert Frantz, MD | |
Sub-Investigator: Garvan Kane, MD | |
Sub-Investigator: Grace Lin, MD | |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Richard Krasuski, MD krasusr@ccf.org | |
Contact: Mario Becerra (216) 445-1647 BECERRM@ccf.org | |
Principal Investigator: Richard Krasuski, MD | |
Sub-Investigator: Wael Mallah, MD | |
United States, Pennsylvania | |
Allegheny General Hospital | Recruiting |
Pittsburgh, Pennsylvania, United States, 15212 | |
Contact: Amresh Raina, MD araina@wpahs.org | |
Contact: Pranav Ravi pravi@wpahs.org | |
Principal Investigator: Amresh Raina, MD | |
Sub-Investigator: Robert Biederman, MD | |
United States, Texas | |
Baylor | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Adaani Frost, MD 713-798-2400 frost@bcm.edu | |
Contact: Helena Purl, RN BSN 713-798-2400 hpurl@bcm.edu | |
Principal Investigator: Adaani Frost, MD | |
Canada, Ontario | |
Toronto General Hospital | Recruiting |
Tononto, Ontario, Canada, M5G-2C4 | |
Contact: John Granton, MD 647-225-4485 drjohn.granton@uhn.ca | |
Contact: Rima Hosn 416-340-4800 ext 8181 rihosn@uhnres.toronto.ca | |
Principal Investigator: John Granton, MD |
Principal Investigator: | Robyn Barst, MD | Scientific Advisory Board |
![](https://webarchive.library.unt.edu/web/20130305102926im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | VentriPoint Diagnostics Ltd. |
ClinicalTrials.gov Identifier: | NCT01557582 History of Changes |
Other Study ID Numbers: | 2011052 |
Study First Received: | August 30, 2011 |
Last Updated: | October 5, 2012 |
Health Authority: | United States: Food and Drug Administration |
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:
Hypertension, Pulmonary Hypertension Lung Diseases |
Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2013