Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
NCT ID: NCT02645539
Last Updated: 2019-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-04-30
2020-12-31
Brief Summary
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Detailed Description
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Data obtained from the study will be used to make device modifications, refine the patient population, and inform the design a future clinical trial suitable for assessing longer-term use in heart failure patients.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
All patients are treated with the intravascular ventricular assist system (iVAS).
intravascular ventricular assist system (iVAS)
A mechanical circulatory support device using the principles of counterpulsation.
Interventions
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intravascular ventricular assist system (iVAS)
A mechanical circulatory support device using the principles of counterpulsation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. If female, are postmenopausal or surgically sterilized, or have a negative pregnancy test within seven (7) days of invasive testing.
3. Advanced heart failure (NYHA Class III or IV)
Exclusion Criteria
2. Receiving more than two inotropes.
3. Subclavian stenosis or stent.
4. Currently receiving circulatory support including ECMO, Impella, TandemLife or equivalents; or any durable VAD.
5. Atrial fibrillation without ventricular pacing.
6. Concomitant, non-cardiac disease process with life expectancy \< 1 year.
7. Significant abnormalities of the aorta, such as aneurysms, coarctation of the aorta, or an extremely tortuous aorta.
8. Severe end-organ dysfunction or failure.
9. Any other condition the heart team believes inappropriate for this study.
18 Years
ALL
No
Sponsors
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NuPulseCV
INDUSTRY
Responsible Party
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Locations
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Advent Health
Orlando, Florida, United States
University of Chicago Medicine
Chicago, Illinois, United States
NorthShore University Health System
Evanston, Illinois, United States
Saint Vincent Hospital
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Saint Luke's Mid-America Heart Institute
Kansas City, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
New York University
New York, New York, United States
Columbia University Medical Center / New York-Presbyterian Hospital
New York, New York, United States
Duke University
Durham, North Carolina, United States
Abington Hospital - Jefferson Health
Abington, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Houston Methodist Research Institute
Houston, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Ezequiel Molina
Role: primary
Scott Silvestry
Role: primary
Colleen Juricek
Role: primary
Robert Gordon
Role: primary
Christopher Salerno
Role: primary
Mark Slaughter
Role: primary
Aditya Bansal
Role: primary
Michael Givertz
Role: primary
Ranjit John
Role: primary
John Um
Role: primary
Deane Smith
Role: primary
Koji Takeda
Role: primary
Carmelo Milano
Role: primary
Donald Haas
Role: primary
Robert Dowling
Role: primary
Erik Suarez
Role: primary
Craig Selzman
Role: primary
References
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Uriel N, Jeevanandam V, Imamura T, Onsager D, Song T, Ota T, Juricek C, Combs P, Lammy T, Patel-Raman S, Woolley JR, Sayer G, Milano C, Schroder J, Molina E, Grinstein J, Suarez E, Estep JD, Aggarwal S, Silvestry S, Raval N; iVAS Investigators. Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial. Circ Heart Fail. 2020 Apr;13(4):e006666. doi: 10.1161/CIRCHEARTFAILURE.119.006666. Epub 2020 Apr 8.
Other Identifiers
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PRO-10001
Identifier Type: -
Identifier Source: org_study_id
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