ThromboembolismNCT04199793
Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device
A study testing Lavare On and Lavare Off in people with Thromboembolism and Hemolysis, run by Vanderbilt University Medical Center at 4 sites in United States.
Trial summary
Left ventricular assist device (LVAD) patients remain at risk for pump thrombus and thromboembolic events through multiple mechanisms. The HeartWare® Ventricular Assist System (HVAD®, HeartWare Inc., Framingham, MA, USA) includes a novel speed modulation feature called Lavare™ cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboembolism, Hemolysis, Stroke
- What is being tested?
- Lavare On and Lavare Off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Aug 2020to 10 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Approved for or supported with HeartWare durable LVAD
- Capable of giving informed consent
Who cannot join
- For those undergoing new device implantation:
- Age <18 years
- Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 at the time of implantation
- Presence of intra-cardiac thrombus
- History of thromboembolic event within previous 3 months of enrollment
- For those with prior LVAD implantation with on-going support:
Show all 16Show fewer
- Support duration <3 months
- History of prior LVAD pump exchange
- History of LVAD pump hemolysis or thrombosis as defined by INTERMACS criteria
- History of stroke or transient ischemic event within previous 3 months of enrollment
- History of post-LVAD severe right ventricular failure as defined by INTERMACS criteria within previous 3 months of enrollment
- History of pump-related infection treated within previous 3 months of enrollment or those on chronic antibiotics suppressive therapy for pump related infection
- History of post-LVAD intra-cardiac or arterial thrombus or thromboembolic event within previous 3 months of enrollment
- International Normalized Ratio (INR) <2 within previous 30-days from the date of enrollment
- Aspirin dose <325 mg/day
- Lactate Dehydrogenase (LDH) levels ≥ 3 times the upper normal limit in previous 3 months
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
St Vincent Hospital Indianapolis
Indianapolis, Indiana, 46290
Vanderblt University Medical Center
Nashville, Tennessee, 37232
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
About this study
Official title: Assessment of Lavare Cycle Implementation Among Patients Following HeartWare Left Ventricular Assist Device Implantation: A Prospective Randomized Controlled Pilot Study
Left ventricular assist device (LVAD) patients remain at risk for pump thrombus and thromboembolic events through multiple mechanisms. The HeartWare® Ventricular Assist System (HVAD®, HeartWare Inc., Framingham, MA, USA) includes a novel speed modulation feature called Lavare™ cycle. The Lavare™ Cycle is aimed to promote washing of left ventricle to decrease blood stasis and subsequent risk of thrombus formation, ingestion and/or expulsion. No prior study has prospectively evaluated the impact of Lavare™ cycle on patient outcomes in a randomized fashion. We intend to assess effects of Lavare™ Cycle among patients receiving HVAD LVAD in this randomized controlled pilot project.
Read the detailed description
Left ventricular assist device (LVAD) patients remain at risk for pump thrombus and thromboembolic events through multiple mechanisms. The HeartWare® Ventricular Assist System (HVAD®, HeartWare Inc., Framingham, MA, USA) includes a novel speed modulation feature called Lavare™ cycle. It consists of 3 phases: phase 1 - a 200 rpm decrease from baseline speed for 2 seconds, phase 2 - a 100 rpm increase from baseline for 1 second and phase 3 - return of speed to baseline; this cycle repeats itself once every minute.
The LavareTM Cycle is aimed to promote washing of left ventricle to decrease blood stasis and subsequent risk of thrombus formation, ingestion and/or expulsion. In a post-hoc analysis of ReVOLVE registry, which includes 248 patients implanted with the HVAD following Conformité Européenne Mark in nine centers in Europe and Australia, no adverse impact on survival was observed with Lavare™ cycle. Additionally, lower risk of stroke, sepsis and right heart failure was observed among those with Lavare™ cycle in the above-mentioned study. However, no prior study has prospectively evaluated the impact of Lavare™ cycle on patient outcomes in a randomized fashion. In this prospective randomized controlled trial, we intend to assess the role of Lavare™ cycle in pump related complications.
- Conditions
- Thromboembolism, Hemolysis, Stroke
- Being tested
- Lavare On, Lavare Off
- Keywords
- Lavare Cycle, HeartWare LVAD, Thromboembolic events
- Medical subject headings
- Thromboembolism, Hemolysis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavare OnDevice
For the patients randomized to "Lavare On" group, the Lavare™ cycle will be turned on upon device interrogation after patients return to intensive care unit from the operating room.
Lavare OffDevice
For the patients randomized to "Lavare Off" group, the Lavare™ cycle will be turned off upon device interrogation after patients return to intensive care unit from the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Lavare Cycle On | Active comparator | For the patients randomized to "Lavare On" group, the Lavare™ cycle will be turned on upon device interrogation after patients return to intensive care unit from the operating room. Receives: Device: Lavare On |
| Lavare Cycle Off | Active comparator | For the patients randomized to "Lavare Off" group, the Lavare™ cycle will be turned off upon device interrogation after patients return to intensive care unit from the operating room. Receives: Device: Lavare Off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint of Total Ischemic Events, Thromboembolic Events, Pump Hemolysis or Thrombosis, Pump Exchange
INTERMACS definitions of cerebrovascular events, pump hemolysis/ thrombosis will be used. Pump malfunction needing device exchange or emergent transplant will also be included in the main composite event
Measured: 6 months
Secondary outcomes (10)
All-cause Mortality
death from any cause
Measured: 6 months
Survival to Transplantation
Number of days supported on LVAD until transplant
Measured: 6 months
Rehospitalizations
Any cardiac and non-cardiac re-hospitalizations since trial enrollment
Measured: 6 months
Mucosal Bleeding
Epistaxis, gastrointestinal bleeding, urological bleeding events will be analyzed
Measured: 6 months
Right Ventricular Failure
INTERMACS definitions for Right ventricular failure will be analyzed
Measured: 6 months
Device Related Infection
LVAD device systems related infections will be analyzed
Measured: 6 months
Aortic Insufficiency
Echocardiographic evidence will be used to define severity of aortic insufficiency
Measured: 6 months
Change in 6 Minute Walk Test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Baseline to 6 months
Changes in New York Heart Association Class
Functional class will be assessed at baseline and during follow up to assess improvement in functional status
Measured: Baseline to 6 months
Quality of Life Measured by The Kansas City Cardiomyopathy Questionnaire
Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The score can range from 0-100, in which higher scores reflect better health status.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start10 Aug 2020
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Why it stopped: The device (HeartWare) was recalled and discontinued by the FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandip Zalawadiya, Vanderbilt University Medical Center
- Investigators
- Sandip Zalawadiya, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199793
- Sponsor's protocol ID
- HeartWareLavare1
- Status last verified
- Nov 2022
- First submitted
- 12 Dec 2019
- Last updated
- 12 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zimpfer D, Strueber M, Aigner P, Schmitto JD, Fiane AE, Larbalestier R, Tsui S, Jansz P, Simon A, Schueler S, Moscato F, Schima H. Evaluation of the HeartWare ventricular assist device Lavare cycle in a particle image velocimetry model and in clinical practice. Eur J Cardiothorac Surg. 2016 Nov;50(5):839-848. doi: 10.1093/ejcts/ezw232. Epub 2016 Sep 7.
PubMed 27605222
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lavare Cycle Implementation Among Patients Following HeartWare Left Ventricular Assist Device Implantation: A Prospective Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04199793
- Acronym / sponsor ID
- HeartWareLavare1
- Conditions
- Thromboembolism, Hemolysis, Stroke
- Keywords
- Lavare Cycle, HeartWare LVAD, Thromboembolic events
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The device (HeartWare) was recalled and discontinued by the FDA
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Posted 12 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Left ventricular assist device (LVAD) patients remain at risk for pump thrombus and thromboembolic events through multiple mechanisms. The HeartWare® Ventricular Assist System (HVAD®, HeartWare Inc., Framingham, MA, USA) includes a novel speed modulation feature called Lavare™ cycle. The Lavare™ Cycle is aimed to promote washing of left ventricle to decrease blood stasis and subsequent risk of thrombus formation, ingestion and/or expulsion. No prior study has prospectively evaluated the impact of Lavare™ cycle on patient outcomes in a randomized fashion. We intend to assess effects of Lavare™ Cycle among patients receiving HVAD LVAD in this randomized controlled pilot project.
Detailed description
Left ventricular assist device (LVAD) patients remain at risk for pump thrombus and thromboembolic events through multiple mechanisms. The HeartWare® Ventricular Assist System (HVAD®, HeartWare Inc., Framingham, MA, USA) includes a novel speed modulation feature called Lavare™ cycle. It consists of 3 phases: phase 1 - a 200 rpm decrease from baseline speed for 2 seconds, phase 2 - a 100 rpm increase from baseline for 1 second and phase 3 - return of speed to baseline; this cycle repeats itself once every minute.
The LavareTM Cycle is aimed to promote washing of left ventricle to decrease blood stasis and subsequent risk of thrombus formation, ingestion and/or expulsion. In a post-hoc analysis of ReVOLVE registry, which includes 248 patients implanted with the HVAD following Conformité Européenne Mark in nine centers in Europe and Australia, no adverse impact on survival was observed with Lavare™ cycle. Additionally, lower risk of stroke, sepsis and right heart failure was observed among those with Lavare™ cycle in the above-mentioned study. However, no prior study has prospectively evaluated the impact of Lavare™ cycle on patient outcomes in a randomized fashion. In this prospective randomized controlled trial, we intend to assess the role of Lavare™ cycle in pump related complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavare Cycle On | Active comparator | Device: Lavare OnFor the patients randomized to "Lavare On" group, the Lavare™ cycle will be turned on upon device interrogation after patients return to intensive care unit from the operating room. |
| Lavare Cycle Off | Active comparator | Device: Lavare OffFor the patients randomized to "Lavare Off" group, the Lavare™ cycle will be turned off upon device interrogation after patients return to intensive care unit from the operating room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Approved for or supported with HeartWare durable LVAD
- Capable of giving informed consent
Key exclusion criteria (16 listed)
- For those undergoing new device implantation:
- For those with prior LVAD implantation with on-going support:
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 |
|---|---|---|
| Lavare OnFor the patients randomized to "Lavare On" group, the Lavare™ cycle will be turned on upon device interrogation after patients return to intensive care unit from the operating room. | Device | Lavare Cycle On |
| Lavare OffFor the patients randomized to "Lavare Off" group, the Lavare™ cycle will be turned off upon device interrogation after patients return to intensive care unit from the operating room. | Device | Lavare Cycle Off |
Primary outcome
Composite Endpoint of Total Ischemic Events, Thromboembolic Events, Pump Hemolysis or Thrombosis, Pump Exchange
Time frame: 6 months
INTERMACS definitions of cerebrovascular events, pump hemolysis/ thrombosis will be used. Pump malfunction needing device exchange or emergent transplant will also be included in the main composite event
10 secondary outcomes
All-cause Mortality
Time frame: 6 months
Survival to Transplantation
Time frame: 6 months
Rehospitalizations
Time frame: 6 months
Mucosal Bleeding
Time frame: 6 months
Right Ventricular Failure
Time frame: 6 months
Device Related Infection
Time frame: 6 months
Aortic Insufficiency
Time frame: 6 months
Change in 6 Minute Walk Test
Time frame: Baseline to 6 months
Changes in New York Heart Association Class
Time frame: Baseline to 6 months
Quality of Life Measured by The Kansas City Cardiomyopathy Questionnaire
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27605222Zimpfer D, Strueber M, Aigner P, Schmitto JD, Fiane AE, Larbalestier R, Tsui S, Jansz P, Simon A, Schueler S, Moscato F, Schima H. Evaluation of the HeartWare ventricular assist device Lavare cycle in a particle image velocimetry model and in clinical practice. Eur J Cardiothorac Surg. 2016 Nov;50(5):839-848. doi: 10.1093/ejcts/ezw232. Epub 2016 Sep 7.
- Individual participant dataSharing planned: No
Related trials for Thromboembolism
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
Sandip Zalawadiya, MD principal investigator
Vanderbilt University Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavare On and Lavare Off in people with Thromboembolism and Hemolysis, run by Vanderbilt University Medical Center at 4 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 3 inclusion and 16 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: stopped early, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 12 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite Endpoint of Total Ischemic Events, Thromboembolic Events, Pump Hemolysis or Thrombosis, Pump Exchange (time frame: 6 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 NCT04199793, which also lists 1 linked publication.
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 12 Dec 2022.