PREVENtion of HeartMate II Pump Thrombosis



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:2/6/2019
Start Date:September 2014
End Date:June 2016

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PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management

The purpose of this study is to assess how often blood clots form in the FDA-approved
HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to
clotting within the pump.

PREVENT is a prospective, multi-center, non-randomized study that is designed (1) to assess
the incidence of HM II pump thrombosis in the current era when recommended practices for
clinical management are adopted, and (2) to identify the risk factors associated with pump
thrombosis events. The recommended practices are focused on implantation technique,
anticoagulation regimen, pump speed and blood pressure management. All consecutive patients
receiving a HM II implant will be considered for this study.

Inclusion Criteria:

- Subject or legally authorized representative has signed an informed consent form

- Subject is receiving the HeartMate II as their first Left Ventricular Assist Device
(LVAD)

Exclusion Criteria:

- Prior mechanical circulatory support (MCS) (except for intra-aortic balloon pump)

- Participation in any other clinical investigation(s) involving a MCS device, or an
investigation(s) that is likely to confound study results or affect study outcome
We found this trial at
23
sites
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
2118
mi
from 91732
Pittsburgh, PA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
1730
mi
from 91732
Chicago, IL
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
2271
mi
from 91732
Falls Church, VA
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2103
mi
from 91732
Gainesville, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
1762
mi
from 91732
Nashville, TN
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
2376
mi
from 91732
Abington, PA
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Aurora, Colorado 80045
820
mi
from 91732
Aurora, CO
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
2194
mi
from 91732
Chapel Hill, NC
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Chicago, Illinois 60601
1730
mi
from 91732
Chicago, IL
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
1879
mi
from 91732
Cincinnati, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
1959
mi
from 91732
Columbus, OH
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Houston, Texas 77030
1358
mi
from 91732
Houston, TX
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
95
mi
from 91732
La Jolla, CA
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Little Rock, Arkansas 72205
1463
mi
from 91732
Little Rock, AR
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
24
mi
from 91732
Los Angeles, CA
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Louisville, Kentucky 40202
1813
mi
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Louisville, KY
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Minneapolis, Minnesota 55407
1509
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Minneapolis, MN
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Minneapolis, Minnesota 55455
1511
mi
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Minneapolis, MN
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
2375
mi
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Philadelphia, PA
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
2121
mi
from 91732
Pittsburgh, PA
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Rochester, Minnesota 55905
1524
mi
from 91732
Rochester, MN
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Sacramento, California 95619
355
mi
from 91732
Sacramento, CA
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
101
mi
from 91732
San Diego, CA
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