HeartMate II Pump ThrombosisPREVENTNCT02158403
PREVENtion of HeartMate II Pump Thrombosis
A study testing Clinical Management Recommendations for reducing pump thrombosis in people with HeartMate II Pump Thrombosis, run by Abbott Medical Devices at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HeartMate II Pump Thrombosis
- What is being tested?
- Clinical Management Recommendations for reducing pump thrombosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 23 sitesUnited States
- Study dates
- Sep 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
University of Colorado
Aurora, Colorado, 80045
University of North Carolina
Chapel Hill, North Carolina, 27599
Northwestern Memorial
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
The Christ Hospital
Cincinnati, Ohio, 45219
Ohio State University
Columbus, Ohio, 43210
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Shands Hospital at University of Florida
Gainesville, Florida, 32610
Memorial Hermann/UT Texas
Houston, Texas, 77030
University of California, San Diego
La Jolla, California, 92037
Baptist Medical Center
Little Rock, Arkansas, 72205
UCLA Medical Center
Los Angeles, California, 90095
Jewish Hospital
Louisville, Kentucky, 40202
Abbott Northwestern
Minneapolis, Minnesota, 55407
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic, St. Mary's
Rochester, Minnesota, 55905
Sutter Memorial
Sacramento, California, 95819
Sharp Memorial Hospital
San Diego, California, 92123
About this study
Official title: 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.
Read the 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.
- Conditions
- HeartMate II Pump Thrombosis
- Being tested
- Clinical Management Recommendations for reducing pump thrombosis
- Keywords
- HeartMate II, heart assist device, pump thrombosis, hypercoagulable disorder, thrombus, Thoratec Corporation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Management Recommendations for reducing pump thrombosisOther
Clinical Management Recommendations for reducing pump thrombosis
| Study group | Role | What they receive |
|---|---|---|
| Clinical Management Recommendations | Other | Clinical management recommendations for reducing pump thrombosis Receives: Other: Clinical Management Recommendations for reducing pump thrombosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation
Measured: 3 months
Secondary outcomes (10)
Incidence of confirmed pump thrombosis within six months of HM II implantation
Measured: 6 months
Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation
Measured: 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
Measured: 3 and 6 months
Survival on LVAD support at six months post HM II implantation
Measured: 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
Measured: 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
Measured: 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)
Measured: 1 week and 6 months after surgery
Characterization of selected lab values (INR, LDH and plasma free Hgb) within the study population
Measured: 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
Measured: 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
Measured: 1 week, 1 month, 3 months, and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HeartMate II Pump ThrombosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- Kartik Sundareswaran, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158403
- Sponsor's protocol ID
- TC05232014
- Acronym
- PREVENT
- Status last verified
- Mar 2022
- First submitted
- 30 May 2014
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36731068Kilic 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.
PubMed 29952801Thenappan 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.
PubMed 29153636
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management
- ClinicalTrials.gov ID
- NCT02158403
- Acronym / sponsor ID
- PREVENT / TC05232014
- Conditions
- HeartMate II Pump Thrombosis
- Keywords
- HeartMate II, heart assist device, pump thrombosis, hypercoagulable disorder, thrombus, Thoratec Corporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Management Recommendations | Other | Other: Clinical Management Recommendations for reducing pump thrombosisClinical management recommendations for reducing pump thrombosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Management Recommendations for reducing pump thrombosisClinical Management Recommendations for reducing pump thrombosis | Other | Clinical Management Recommendations |
Primary outcome
Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation
Time frame: 3 months
10 secondary outcomes
Incidence of confirmed pump thrombosis within six months of HM II implantation
Time frame: 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
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
Survival on LVAD support at six months post HM II implantation
Time frame: 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
Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation
Time frame: 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
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
Incidence of protocol-defined anticipated adverse events
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 36731068Jeske 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.
- Derived from this study: PubMed 29952801Kilic 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.
- Derived from this study: PubMed 29153636Thenappan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kartik Sundareswaran, PhD study director
Abbott
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Management Recommendations for reducing pump thrombosis in people with HeartMate II Pump Thrombosis, run by Abbott Medical Devices at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02158403, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.