Feasibility Study of the Intravascular Ventricular Assist System (iVAS)



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:April 2016
End Date:March 2020
Contact:Lori Rhoten
Email:lori.rhoten@nupulsecv.com

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A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study

The purpose of this feasibility study is to assess the preliminary safety and clinical
performance of the intravascular ventricular assist system (iVAS).

This is a single-arm, non-randomized study designed to assess the preliminary safety and
clinical performance of the NuPulseCV iVAS.

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.

Main Inclusion Criteria:

1. At least 18 years of age.

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)

Main Exclusion Criteria:

1. Hypotension treated with the following medications: epinephrine, norepinephrine,
vasopressin, methylene blue, phenylephrine, or angiotensin II.

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.
We found this trial at
17
sites
Indianapolis, Indiana 46260
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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Chicago, Illinois 60637
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Chicago, IL
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Houston, TX
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Kansas City, Missouri 64111
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Kansas City, MO
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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New Orleans, Louisiana 70121
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New Orleans, LA
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New York, NY
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70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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New York, NY
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Omaha, Nebraska 68198
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Omaha, NE
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Orlando, Florida 32803
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Orlando, FL
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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Salt Lake City, Utah 84132
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Washington, District of Columbia
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Washington,
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