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The device (HeartWare) was recalled and discontinued by the FDA
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lavare On | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | death from any cause | 6 months |
| Survival to Transplantation | Number of days supported on LVAD until transplant | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
For those undergoing new device implantation:
For those with prior LVAD implantation with on-going support:
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| Name | Affiliation | Role |
|---|---|---|
| Sandip Zalawadiya, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Advocate Christ Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27605222 | Result | 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. |
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9 participants signed informed consent. One patient was not randomized due to improved health. Total of 8 patients were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lavare Cycle On | 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 On: 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. |
| FG001 | Lavare Cycle Off | 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. Lavare Off: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lavare Cycle On | 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 On: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Data analysis was not completed because only one participant completed each arm and showing data could violate privacy interests. The department also did not allocate resources for further analysis as the trial was terminated early and was missing sufficient samples and data points for the prespecified analysis. | Posted | 6 months |
|
Baseline to 180-days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lavare Cycle On | 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 On: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rehospitalization due to low INR | Blood and lymphatic system disorders | Systematic Assessment |
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The study was terminated early due to the sponsor withdrew the device off market.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandip Zalawadiya, MBBS | Vanderbilt University Medical Center | 6159368187 | sandip.k.zalawadiya@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2020 | Aug 29, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D006461 | Hemolysis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Lavare Off | Device | 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. |
|
| Rehospitalizations | Any cardiac and non-cardiac re-hospitalizations since trial enrollment | 6 months |
| Mucosal Bleeding | Epistaxis, gastrointestinal bleeding, urological bleeding events will be analyzed | 6 months |
| Right Ventricular Failure | INTERMACS definitions for Right ventricular failure will be analyzed | 6 months |
| Device Related Infection | LVAD device systems related infections will be analyzed | 6 months |
| Aortic Insufficiency | Echocardiographic evidence will be used to define severity of aortic insufficiency | 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. | 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 | 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. | 6 months |
| Oak Lawn |
| Illinois |
| 60453 |
| United States |
| St Vincent Hospital Indianapolis | Indianapolis | Indiana | 46290 | United States |
| Vanderblt University Medical Center | Nashville | Tennessee | 37232 | United States |
| BG001 | Lavare Cycle Off | 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. Lavare Off: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Lavare Cycle Off | 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. Lavare Off: 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. |
|
| Secondary | All-cause Mortality | death from any cause | Data analysis was not completed because only one participant completed each arm and showing data could violate privacy interests. The department also did not allocate resources for further analysis as the trial was terminated early and was missing sufficient samples and data points for the prespecified analysis. | Posted | 6 months |
|
|
| Secondary | Survival to Transplantation | Number of days supported on LVAD until transplant | Data analysis was not completed because only one participant completed each arm and showing data could violate privacy interests. The department also did not allocate resources for further analysis as the trial was terminated early and was missing sufficient samples and data points for the prespecified analysis. | Posted | 6 months |
|
|
| Secondary | Rehospitalizations | Any cardiac and non-cardiac re-hospitalizations since trial enrollment | Data analysis was not completed because only one participant completed each arm and showing data could violate privacy interests. The department also did not allocate resources for further analysis as the trial was terminated early and was missing sufficient samples and data points for the prespecified analysis. | Posted | 6 months |
|
|
| Secondary | Mucosal Bleeding | Epistaxis, gastrointestinal bleeding, urological bleeding events will be analyzed | Data analysis was not completed because only one participant completed each arm and showing data could violate privacy interests. The department also did not allocate resources for further analysis as the trial was terminated early and was missing sufficient samples and data points for the prespecified analysis. | Posted | 6 months |
|
|
| Secondary | Right Ventricular Failure | INTERMACS definitions for Right ventricular failure will be analyzed | Data analysis was not completed because only one participant completed each arm and showing data could violate privacy interests. The department also did not allocate resources for further analysis as the trial was terminated early and was missing sufficient samples and data points for the prespecified analysis. | Posted | 6 months |
|
|
| Secondary | Device Related Infection | LVAD device systems related infections will be analyzed | Data analysis was not completed because only one participant completed each arm and showing data could violate privacy interests. The department also did not allocate resources for further analysis as the trial was terminated early and was missing sufficient samples and data points for the prespecified analysis. | Posted | 6 months |
|
|
| Secondary | Aortic Insufficiency | Echocardiographic evidence will be used to define severity of aortic insufficiency | Data analysis was not completed because only one participant completed each arm and showing data could violate privacy interests. The department also did not allocate resources for further analysis as the trial was terminated early and was missing sufficient samples and data points for the prespecified analysis. | Posted | 6 months |
|
|
| Secondary | 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. | Data analysis was not completed because only one participant completed each arm and showing data could violate privacy interests. The department also did not allocate resources for further analysis as the trial was terminated early and was missing sufficient samples and data points for the prespecified analysis. | Posted | Baseline to 6 months |
|
|
| Secondary | Changes in New York Heart Association Class | Functional class will be assessed at baseline and during follow up to assess improvement in functional status | Data analysis was not completed because only one participant completed each arm and showing data could violate privacy interests. The department also did not allocate resources for further analysis as the trial was terminated early and was missing sufficient samples and data points for the prespecified analysis. | Posted | Baseline to 6 months |
|
|
| Secondary | 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. | Data analysis was not completed because only one participant completed each arm and showing data could violate privacy interests. The department also did not allocate resources for further analysis as the trial was terminated early and was missing sufficient samples and data points for the prespecified analysis. | Posted | 6 months |
|
|
| 0 |
| 4 |
| 2 |
| 4 |
| 0 |
| 4 |
| EG001 | Lavare Cycle Off | 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. Lavare Off: 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. | 0 | 4 | 4 | 4 | 0 | 4 |
| Rehospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pneumothorax requiring chest tube placement; Need for inotropic support during hospitalization. |
|
| Rehospitalization | Surgical and medical procedures | Systematic Assessment | Surgical wound dehiscence requiring wound vac placement |
|
| Rehospitalization | Infections and infestations | Systematic Assessment | Infections of the genitourinary, gastrointestinal and pulmonary systems. |
|
| Right heart failure | Cardiac disorders | Systematic Assessment |
|
| Rehospitalization | Gastrointestinal disorders | Systematic Assessment | Colitis |
|
| Ventricular arrhythmia | Cardiac disorders | Systematic Assessment | Required medications (anti-arrhythmic) adjustments |
|
| Pump/Drive line infection | Infections and infestations | Systematic Assessment |
|
| Other systems infections | Infections and infestations | Systematic Assessment | Not requiring hospitalizations |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Device malfunction alarms | Surgical and medical procedures | Systematic Assessment | Includes controller exchange |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |