PREVENtion of HeartMate II Pump Thrombosis (PREVENT)

March 24, 2022 updated by: Abbott Medical Devices

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Medical Center
    • California
      • La Jolla, California, United States, 92037
        • University of California, San Diego
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Sacramento, California, United States, 95819
        • Sutter Memorial
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands Hospital at University of Florida
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic, St. Mary's
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann/UT Texas
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Clinical Management Recommendations
Clinical management recommendations for reducing pump thrombosis
Other: Clinical Management Recommendations for reducing pump thrombosis
Clinical Management Recommendations for reducing pump thrombosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of confirmed pump thrombosis within six months of HM II implantation
Time Frame: 6 months
6 months
Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation
Time Frame: 3 and 6 months
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
Time Frame: 3 and 6 months
3 and 6 months
Survival on LVAD support at six months post HM II implantation
Time Frame: 6 months
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
Time Frame: Baseline and 1 week, 1 month, 3 months and 6 months after surgery
Baseline and 1 week, 1 month, 3 months and 6 months after surgery
Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation
Time Frame: Baseline and 3 months after implant
Baseline and 3 months after implant
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
1 week and 6 months after surgery
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
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
Incidence of protocol-defined anticipated adverse events
Time Frame: Baseline, 1 month , 3 months and 6 months after surgery
Baseline, 1 month , 3 months and 6 months after surgery
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
1 week, 1 month, 3 months, and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Thoratec Corporation

Investigators

  • Study Director: Kartik Sundareswaran, PhD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

May 30, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC05232014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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