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PREVENtion of HeartMate II Pump Thrombosis (PREVENT)

Primary Purpose

HeartMate II Pump Thrombosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Management Recommendations for reducing pump thrombosis
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HeartMate II Pump Thrombosis focused on measuring HeartMate II, heart assist device, pump thrombosis, hypercoagulable disorder, thrombus, Thoratec Corporation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Medical Center
  • University of California, San Diego
  • UCLA Medical Center
  • Sutter Memorial
  • Sharp Memorial Hospital
  • University of Colorado
  • Shands Hospital at University of Florida
  • Northwestern Memorial
  • University of Chicago
  • Jewish Hospital
  • Abbott Northwestern
  • University of Minnesota Medical Center
  • Mayo Clinic, St. Mary's
  • University of North Carolina
  • The Christ Hospital
  • Ohio State University
  • Abington Memorial Hospital
  • Thomas Jefferson University Hospital
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • Vanderbilt University Medical Center
  • Memorial Hermann/UT Texas
  • Inova Fairfax Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clinical Management Recommendations

Arm Description

Clinical management recommendations for reducing pump thrombosis

Outcomes

Primary Outcome Measures

Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation

Secondary Outcome Measures

Incidence of confirmed pump thrombosis within six months of HM II implantation
Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation
Incidence of pump exchange, urgent transplantation or death due to pump thrombosis within three and six months of HM II implantation
Survival on LVAD support at six months post HM II implantation
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
Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation
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)
Characterization of selected lab values (INR, LDH and plasma free Hgb) within the study population
Incidence of protocol-defined anticipated adverse events
Characterization of pump parameters in the study population including power (watts), speed (rpm), flow (L/min), and pulsatility index

Full Information

First Posted
May 30, 2014
Last Updated
March 24, 2022
Sponsor
Abbott Medical Devices
Collaborators
Thoratec Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02158403
Brief Title
PREVENtion of HeartMate II Pump Thrombosis
Acronym
PREVENT
Official Title
PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
Collaborators
Thoratec Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HeartMate II Pump Thrombosis
Keywords
HeartMate II, heart assist device, pump thrombosis, hypercoagulable disorder, thrombus, Thoratec Corporation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical Management Recommendations
Arm Type
Other
Arm Description
Clinical management recommendations for reducing pump thrombosis
Intervention Type
Other
Intervention Name(s)
Clinical Management Recommendations for reducing pump thrombosis
Intervention Description
Clinical Management Recommendations for reducing pump thrombosis
Primary Outcome Measure Information:
Title
Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Incidence of confirmed pump thrombosis within six months of HM II implantation
Time Frame
6 months
Title
Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation
Time Frame
3 and 6 months
Title
Incidence of pump exchange, urgent transplantation or death due to pump thrombosis within three and six months of HM II implantation
Time Frame
3 and 6 months
Title
Survival on LVAD support at six months post HM II implantation
Time Frame
6 months
Title
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
Time Frame
Baseline and 1 week, 1 month, 3 months and 6 months after surgery
Title
Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation
Time Frame
Baseline and 3 months after implant
Title
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)
Time Frame
1 week and 6 months after surgery
Title
Characterization of selected lab values (INR, LDH and plasma free Hgb) within the study population
Time Frame
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
Title
Incidence of protocol-defined anticipated adverse events
Time Frame
Baseline, 1 month , 3 months and 6 months after surgery
Title
Characterization of pump parameters in the study population including power (watts), speed (rpm), flow (L/min), and pulsatility index
Time Frame
1 week, 1 month, 3 months, and 6 months after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kartik Sundareswaran, PhD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Baptist Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sutter Memorial
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Shands Hospital at University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Northwestern Memorial
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Abbott Northwestern
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic, St. Mary's
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Memorial Hermann/UT Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29952801
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.
Results Reference
derived
PubMed Identifier
29153636
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.
Results Reference
derived

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PREVENtion of HeartMate II Pump Thrombosis

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