Clinical trial NCT02158403: PREVENtion of HeartMate II Pump Thrombosis
Official title: PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HeartMate II Pump Thrombosis
Keywords: HeartMate II
heart assist device
pump thrombosis
hypercoagulable disorder
thrombus
Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Corporation
First posted: 2014-06-06
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of confirmed pump thrombosis within six months of HM II implantation
timeFrame: 6 months
measure: Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation
timeFrame: 3 and 6 months
measure: Incidence of pump exchange, urgent transplantation or death due to pump thrombosis within three and six months of HM II implantation
timeFrame: 3 and 6 months
measure: Survival on LVAD support at six months post HM II implantation
timeFrame: 6 months
measure: 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
timeFrame: Baseline and 1 week, 1 month, 3 months and 6 months after surgery
measure: Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation
timeFrame: Baseline and 3 months after implant
measure: Characterization of pump position in the study population (measured via quantitative assessment of X-ray images including inflow cannula angle, outflow cannula angle and pump pocket depth)
timeFrame: 1 week and 6 months after surgery
measure: Characterization of selected lab values (INR, LDH and plasma free Hgb) within the study population
timeFrame: Baseline, 1 week (plus or minus 3 days), 1 month (plus or minus 7 days), 3 months and 6 months (plus or minus 30 days) after surgery
measure: Incidence of protocol-defined anticipated adverse events
timeFrame: Baseline, 1 month , 3 months and 6 months after surgery
measure: Characterization of pump parameters in the study population including power (watts), speed (rpm), flow (L/min), and pulsatility index
timeFrame: 1 week, 1 month, 3 months, and 6 months after surgery
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Baptist Medical Center
state: Arkansas
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Memorial
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Gainesville
country: United States
facility: Shands Hospital at University of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Minneapolis
country: United States
facility: Abbott Northwestern
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic, St. Mary's
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Memorial Hermann/UT Texas
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: Abbott
name: Kartik Sundareswaran, PhD
role: STUDY_DIRECTOR
References:
citation: Kilic 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.
citation: Thenappan 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.