Trial Outcomes & Findings for Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device (NCT NCT04199793)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

6 months

Results posted on

2022-12-12

Participant Flow

9 participants signed informed consent. One patient was not randomized due to improved health. Total of 8 patients were randomized.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	4	4
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Sponsor Withdrew the device off market; study stopped	2	2
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lavare Cycle On n=4 Participants 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.	Lavare Cycle Off n=4 Participants 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.	Total n=8 Participants Total of all reporting groups
Age, Continuous	55 years n=5 Participants	54.5 years n=7 Participants	54.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

death from any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Number of days supported on LVAD until transplant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Any cardiac and non-cardiac re-hospitalizations since trial enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Epistaxis, gastrointestinal bleeding, urological bleeding events will be analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

INTERMACS definitions for Right ventricular failure will be analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

LVAD device systems related infections will be analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Echocardiographic evidence will be used to define severity of aortic insufficiency

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: 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.

Functional class will be assessed at baseline and during follow up to assess improvement in functional status

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Lavare Cycle On

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Lavare Cycle Off

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lavare Cycle On n=4 participants at risk 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.	Lavare Cycle Off n=4 participants at risk 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.
Blood and lymphatic system disorders Rehospitalization due to low INR	25.0% 1/4 • Number of events 1 • 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.	25.0% 1/4 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Rehospitalization	25.0% 1/4 • Number of events 1 • 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.	0.00% 0/4 • 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.
Surgical and medical procedures Rehospitalization	0.00% 0/4 • 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.	25.0% 1/4 • Number of events 1 • 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.
Infections and infestations Rehospitalization	0.00% 0/4 • 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.	25.0% 1/4 • Number of events 1 • 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.
Cardiac disorders Right heart failure	0.00% 0/4 • 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.	25.0% 1/4 • Number of events 1 • 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.
Gastrointestinal disorders Rehospitalization	0.00% 0/4 • 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.	25.0% 1/4 • Number of events 1 • 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.
Cardiac disorders Ventricular arrhythmia	25.0% 1/4 • Number of events 1 • 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.	25.0% 1/4 • Number of events 1 • 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.
Infections and infestations Pump/Drive line infection	0.00% 0/4 • 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.	50.0% 2/4 • Number of events 2 • 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.
Infections and infestations Other systems infections	0.00% 0/4 • 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.	50.0% 2/4 • Number of events 2 • 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.
Blood and lymphatic system disorders Bleeding	0.00% 0/4 • 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.	25.0% 1/4 • Number of events 1 • 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.
Surgical and medical procedures Device malfunction alarms	25.0% 1/4 • Number of events 1 • 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.	25.0% 1/4 • Number of events 1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Sandip Zalawadiya, MBBS

Vanderbilt University Medical Center

Phone: 6159368187

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place