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

Use our guide to learn which trials are right for you!

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
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
Omaha, Nebraska 68198
?
mi
from
Omaha, NE
Click here to add this to my saved trials
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...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Washington, District of Columbia
?
mi
from
Washington,
Click here to add this to my saved trials