PREVENtion of HeartMate II Pump Thrombosis
PREVENT
1 other identifier
interventional
300
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMarch 25, 2022
March 1, 2022
1.5 years
May 30, 2014
March 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation
3 months
Secondary Outcomes (10)
Incidence of confirmed pump thrombosis within six months of HM II implantation
6 months
Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation
3 and 6 months
Incidence of pump exchange, urgent transplantation or death due to pump thrombosis within three and six months of HM II implantation
3 and 6 months
Survival on LVAD support at six months post HM II implantation
6 months
Multivariate analysis of risk factors for pump thrombosis including demographics, anti-coagulation regimen, selected laboratory data (INR, LDH, plasma free Hgb), pump position measures, pump parameters and blood pressure
Baseline and 1 week, 1 month, 3 months and 6 months after surgery
- +5 more secondary outcomes
Study Arms (1)
Clinical Management Recommendations
OTHERClinical management recommendations for reducing pump thrombosis
Interventions
Clinical Management Recommendations for reducing pump thrombosis
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Medical Deviceslead
- Thoratec Corporationcollaborator
Study Sites (23)
Baptist Medical Center
Little Rock, Arkansas, 72205, United States
University of California, San Diego
La Jolla, California, 92037, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Sutter Memorial
Sacramento, California, 95819, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
University of Colorado
Aurora, Colorado, 80045, United States
Shands Hospital at University of Florida
Gainesville, Florida, 32610, United States
Northwestern Memorial
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Abbott Northwestern
Minneapolis, Minnesota, 55407, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic, St. Mary's
Rochester, Minnesota, 55905, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Ohio State University
Columbus, Ohio, 43210, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Memorial Hermann/UT Texas
Houston, Texas, 77030, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Related Publications (3)
Jeske W, Ransom J, Katz JN, Kilic A, Lindenfeld J, Egnaczyk G, Shah P, Brieke A, Uriel N, Crandall D, Farrar DJ, Walenga JM. Enhanced Thrombin Formation in Patients With Ventricular Assist Devices Experiencing Bleeding: Insights From the Multicenter PREVENT Study. ASAIO J. 2023 Mar 1;69(3):278-283. doi: 10.1097/MAT.0000000000001790. Epub 2022 Sep 8.
PMID: 36731068DERIVEDKilic A, Ransom J, Maltais S, Sun B, Entwistle JW 3rd, Bailey S, John R, Klodell CT, Gregoric I, Sheridan B, Chuang J, Farrar DJ, Sundareswaran K, Adamson R. Pump Position Impacts HeartMate II Left Ventricular Assist Device Thrombosis. ASAIO J. 2019 Mar/Apr;65(3):227-232. doi: 10.1097/MAT.0000000000000840.
PMID: 29952801DERIVEDThenappan T, Stulak JM, Agarwal R, Maltais S, Shah P, Eckman P, Emani S, Katz JN, Gregoric I, Keebler ME, Uriel N, Adler E, Chuang J, Farrar DJ, Sundareswaran KS, John R. Early intervention for lactate dehydrogenase elevation improves clinical outcomes in patients with the HeartMate II left ventricular assist device: Insights from the PREVENT study. J Heart Lung Transplant. 2018 Jan;37(1):25-32. doi: 10.1016/j.healun.2017.10.017. Epub 2017 Oct 24.
PMID: 29153636DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kartik Sundareswaran, PhD
Abbott
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2014
First Posted
June 6, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2016
Study Completion
June 1, 2016
Last Updated
March 25, 2022
Record last verified: 2022-03