Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06039176 |
| Other study ID # |
ICCAC |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2023 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
September 2023 |
| Source |
International Consortium of Circulatory Assist Clinicians |
| Contact |
Sarah E Schroeder, PhD MSN RN |
| Phone |
402-937-3595 |
| Email |
sarah.schroeder[@]vadcoordinator.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid
to late 1990s, with an uptick of utility starting in 2010 following expanded indications for
therapy to not only include a bridge to transplantation strategy, but also for those
individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac
transplantation. Despite the decreasing size of the newest generation devices leading to a
lessened occurrence of adverse events, bleeding and infection still remain a concern for
clinicians, as well as a general lack of predictability towards adverse events in individuals
with a dLVAD in place. There is a lack of description in the literature currently, regarding
the interface between what the pump data provides and what is seen in clinical practice.
There also is little known about the effects of what is provided in the pump data, in
correlation to quality-of-life following dLVAD implantation.
Therefore, the purpose of this study is to prospectively analyze normal and abnormal pump
data through pump operations such as suction events, low flow alarms as well as other
adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the
HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty
and other various medical conditions and adverse events as defined by the Interagency
Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved
through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical
practice application (quality of life, frailty and various medical conditions, and adverse
events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate
correlations and relationships of longitudinal normal and abnormal dLVAD pump operations
data, to demographic and clinical variables. This study is the first study to evaluate
HeartMate 3 ® dLVAD pump operations data over time for effectiveness in the clinical
practice.
Description:
Specific Aims The prevalence of heart failure (HF), a chronic medical condition, continues to
grow exponentially, affecting more than 26 million globally. There are more than 6.5 million
in the United States alone with HF. Roughly 600,000 individuals suffer from end-stage HF,
defined as advanced structural changes to the heart, significantly worsening HF symptoms
despite medical therapy, and generally more than 50% 1-year mortality risk. 1-4 There are
limited treatment options once traditional guideline driven medical therapy fails in those
advancing to end-stage HF. Limited treatment options at this point have included
consideration of cardiac transplantation or implantation of a durable left ventricular assist
device (dLVAD), or proceeding down the path of palliative care and hospice. One-year
mortality risk without a dLVAD is nearing now 80%, 5,6 as opposed to one-year survival with a
dLVAD approaching 75-80%. 7,8 Once a dLVAD is placed, concern continues of predicting adverse
events. Multiple groups have utilized different strategies to predict the risk of bleeding,
stroke and infection, yet not one strategy alone is all-encompassing of these three adverse
events. Bleeding risk following dLVAD implantation ranges between 15-68%,9 while the risk of
infection is estimated between 19-39%.10 The risk of stroke with dLVADs is as high as 10%.11
Prior to market removal, researchers utilizing the HeartWare ® (or HVAD) have analyzed
waveform and pump data to predict or determine sequencing of adverse events.12 This study
through machine learning, found that bleeding and right heart failure (RHF) were the most
commonly found adverse events with the earliest onset, while infection and bleeding were the
most common adverse events overall after three months on device.12 While additional pump data
analyses exist for other centrifugal flow pumps, there is a significant gap in the literature
where little information is known of how the HeartMate 3 ® dLVAD pump operations data (such
as suction events, low flow alarms and other adventitious alarms, PI events and incidence of
power cable disconnects greater than 20 seconds) interfaces with quality of life (QOL),
frailty and other various medical conditions, as well as how additional pump data may predict
future adverse events such as gastrointestinal bleeding (GIB), RHF, infection, hypertension,
arrhythmias or stroke. Clinicians caring for individuals with a HeartMate 3 ® devices are not
aware at this time how pump operations data correlates to the clinical component of care,
thus demonstrating the importance of this study.
To address the gap of how the HeartMate 3 ® dLVAD pump data interfaces with clinical care,
this prospective, multi-center trial will analyze the normal and abnormal pump operations
data (such as suction events, low flow alarms and other adventitious alarms, PI events or
incidence of power cable disconnects) from HeartMate 3 ® dLVADs for clinical correlations to
QOL, severity of frailty, various medical conditions, and adverse events at ten different
centers worldwide. Currently there are no mandatory guidelines for pump operations data
downloads in the instructions-for-use manual, only recommendations from each individual
company. Researchers have been challenged to think outside the box of what information has
yet to be divulged from normal and abnormal pump operations in order to assist clinicians in
better care as the evolution of smaller and smarter to devices occur.13 In this study, we
hypothesize the following: 1.) there will be correlations between abnormal hemodynamic pump
operations (e.g. suction events, low flow alarms and other adventitious alarms, "PI" events,
and power cable disconnects greater than 20 seconds), and worsening quality of life; 2.)
worsening severity of frailty will demonstrate increased power cable disconnects and/or
increased use of the power module "A/C" power, due to handling mistakes or less mobility; 3.)
early stages of gastrointestinal bleeding will be seen with abnormal hemodynamic pump
operations (such as suction events) 3-7 days prior to the actual event of being symptomatic;
and 4.) patients with GIB or RHF will have lower PI values in comparison to those that do not
have adverse events, when having comparable set speeds. In order to meet the objectives with
the purpose of this study, two aims have been established:
Aim #1: Evaluate the effectiveness of HeartMate 3 ® dLVAD normal and abnormal pump operations
data on clinical practice applications when utilizing downloadable pump data analyses at
several time points following implantation: discharge from the intensive care unit (ICU),
discharge from the hospital (minimum over a week post implant and +/- 3 days from discharge),
3-months post dLVAD, 6-months post dLVAD, and 12-months post dLVAD. Data will also be
collected during any unplanned office visits, any admission regardless of the reason,
unplanned Emergency Room (ER) visits related to equipment problems or any serious adverse
event related ER visits. Clinical practice applications include: QOL, severity of frailty and
other various medical conditions, and adverse events such as GIB, RHF, infection,
hypertension, arrhythmias and stroke.
Aim #2: Evaluate correlations and relationships between longitudinal normal and abnormal
dLVAD pump operations data, to demographic and clinical variables (e.g. age, gender, length
of stay, Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
score, co-morbidities, eyeball frailty test, laboratory values, EQ-5D and Visual Analog
Scale, Mini-Cog ©, physical frailty measurements through 6-Minute Walk Test and Sit-to-Stand
Chair rise test, anticoagulation strategies, cardiopulmonary bypass time, intubation to
extubation time, temporary support prior to and following dLVAD implantation, concomitant
surgeries, post-surgical complications, and echocardiography results).
Significance Individuals caring for HeartMate 3 ® dLVAD recipients oftentimes rely on
industry interpretation of waveforms and pump data in urgent clinical situations. However,
there may be limitations in how quick this information is provided to the clinicians to piece
the puzzle together. There is limited pump operations data research directly available to the
clinician to demonstrate the interface connection towards clinical practical applications, or
relationships with other co-morbid conditions and adverse events as previously mentioned.
With persistent adverse events in the dLVAD population, more information pertaining to the
clinical situation is always helpful. There has only been data reported on the Heartware ®
system with regards to real time data. For example, HeartWare ® log files and pump operations
data have been analyzed to identify ingestion of pump thrombosis,14 while suggestions have
begun to start using patient monitoring through the HeartMate 3 ® dLVAD system.15 To date,
there is scarce literature to describe the HeartMate 3 ® dLVAD pump operations data within
the clinical interface. More importantly, clinicians are not aware of added benefits from
dLVADs unless shared from industry partners.
When a HeartMate 3 ® dLVAD patient presents with a problem or suspected adverse event,
current practice and recommendations from industry is to download the log files and pump
operations data, and submit directly to the Abbott ® team to further provide insight from
industry of any potential problems occurring directly with the device. This download is quick
and can be done by ventricular assist device (VAD) coordinators or other staff in the
hospital or clinic, however the analysis results themselves can at times, take up to a few
hours to learn mostly what is already being seen by the clinician performing the download.
The Medical University of Vienna team has the ability to interpret routine and available
downloadable pump operations data through file analyses when downloading files using the
Abbott ® display screens or HeartMate Touch ® systems. This advancement from the Medical
University of Vienna will provide additional analysis efforts in this study following pump
operations data retrieval.
Despite attempts of medical care being guided towards prevention, health care often times
resorts to reactionary care instead, by no fault of our own. If clinicians had the capability
of predicting adverse events, what affects QOL and what may lessen the severity of frailty or
other affects towards medical conditions based upon the downloadable pump operations data
alone, the health care pendulum would swing back towards the efforts of prevention, lessening
cost and improving overall QOL. There have been speculations of utilizing dLVADs as a means
for patient monitoring, leading clinicians to consider recommendations of needing wireless
transmission of real time dLVAD pump operations data at any point throughout the life of a
dLVAD, including while at home, at routine care appointments and when things arise or
symptoms occur. This would be a similar process in how an automated internal cardiac
defibrillator patient sends in a manual transmission download for the clinician to further
evaluate any rhythm disturbances. This is a major gap in the functional reporting of a dLVAD
and can actually hinder the care provided by the clinician seeing the patient. This has led
to the development of this study.
Previous reports have discussed analyzing pump data on the HeartWare ® device. This pump has
now been removed from the market for implantation purposes, but this research paved the way
for future needs of clinicians when it comes down to the care of a dLVAD patient. One thing
learned through the recent SARS-CoV-19 pandemic is the benefit and utility of remote
monitoring for ongoing patient care across the spectrum of healthcare, in order to assist in
resource allocation.16 Clinicians caring for dLVAD patients need to further investigate
predictive models and causal relationships of pump operations data to QOL, the severity of
frailty, advancement of other medical conditions and adverse events such as GIB, RHF,
infection, hypertension, arrhythmias and stroke. The study's primary end point is 12-month
survival post-LVAD implantation stratified by percentage of abnormal pump data. Secondary end
point is to evaluate correlations and relationships between normal and abnormal dLVAD pump
data, to demographic and clinical variables, including longitudinal pump data analyses.
Preliminary Study Work Pilot work regarding HeartMate 3 ® dLVAD pump data analyses began in
2020, where retrospective data was compiled to begin understanding the effects of downloaded
log files to adverse events.17 This pivotal start of research demonstrated there is utility
in HeartMate 3 ® dLVAD log files to determine potential suction events leading to ischemic
strokes. After further discussion between VAD coordinators across the globe, members of the
International Consortium of Circulatory Assist Clinicians (ICCAC) society suggested to
proceed with further investigation into what further log file interpretation is needed to
provide assistance in clinical care.
This study does not involve any devices being attached to the driveline or other alterations
to the pump or external components. This study is strictly looking at analyses of routinely
available and "downloadable" log files at prospective time points. This grant moves the
science forward in attempts to identify relationships between HeartMate 3 ® dLVAD pump
operations data (both normal and abnormal) regarding QOL, severity of frailty, advancement of
medical conditions and adverse events such as GIB, RHF, infection, hypertension, arrhythmias
and stroke. Currently, standard of practice does not mandatorily dictate when pump data
should be downloaded, with current recommendations being at all of the Intermacs follow-up
appointments.
