Back to resultsLavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device
Primary Purpose
Thromboembolism, Hemolysis, Stroke
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lavare On
Lavare Off
Sponsored by
About this trial
This is an interventional supportive care trial for Thromboembolism focused on measuring Lavare Cycle, HeartWare LVAD, Thromboembolic events
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Approved for or supported with HeartWare durable LVAD
- Capable of giving informed consent
Exclusion Criteria:
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:
- 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
Sites / Locations
- University of Alabama at Birmingham
- Advocate Christ Medical Center
- St Vincent Hospital Indianapolis
- Vanderblt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lavare Cycle On
Lavare Cycle Off
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
All-cause Mortality
death from any cause
Survival to Transplantation
Number of days supported on LVAD until transplant
Rehospitalizations
Any cardiac and non-cardiac re-hospitalizations since trial enrollment
Mucosal Bleeding
Epistaxis, gastrointestinal bleeding, urological bleeding events will be analyzed
Right Ventricular Failure
INTERMACS definitions for Right ventricular failure will be analyzed
Device Related Infection
LVAD device systems related infections will be analyzed
Aortic Insufficiency
Echocardiographic evidence will be used to define severity of aortic insufficiency
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.
Changes in New York Heart Association Class
Functional class will be assessed at baseline and during follow up to assess improvement in functional status
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.
Full Information
NCT ID
NCT04199793
First Posted
December 12, 2019
Last Updated
November 11, 2022
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04199793
Brief Title
Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device
Official Title
Assessment of Lavare Cycle Implementation Among Patients Following HeartWare Left Ventricular Assist Device Implantation: A Prospective Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
The device (HeartWare) was recalled and discontinued by the FDA
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism, Hemolysis, Stroke
Keywords
Lavare Cycle, HeartWare LVAD, Thromboembolic events
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lavare Cycle On
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lavare Cycle Off
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lavare On
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Lavare Off
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite Endpoint of Total Ischemic Events, Thromboembolic Events, Pump Hemolysis or Thrombosis, Pump Exchange
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
All-cause Mortality
Description
death from any cause
Time Frame
6 months
Title
Survival to Transplantation
Description
Number of days supported on LVAD until transplant
Time Frame
6 months
Title
Rehospitalizations
Description
Any cardiac and non-cardiac re-hospitalizations since trial enrollment
Time Frame
6 months
Title
Mucosal Bleeding
Description
Epistaxis, gastrointestinal bleeding, urological bleeding events will be analyzed
Time Frame
6 months
Title
Right Ventricular Failure
Description
INTERMACS definitions for Right ventricular failure will be analyzed
Time Frame
6 months
Title
Device Related Infection
Description
LVAD device systems related infections will be analyzed
Time Frame
6 months
Title
Aortic Insufficiency
Description
Echocardiographic evidence will be used to define severity of aortic insufficiency
Time Frame
6 months
Title
Change in 6 Minute Walk Test
Description
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.
Time Frame
Baseline to 6 months
Title
Changes in New York Heart Association Class
Description
Functional class will be assessed at baseline and during follow up to assess improvement in functional status
Time Frame
Baseline to 6 months
Title
Quality of Life Measured by The Kansas City Cardiomyopathy Questionnaire
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Approved for or supported with HeartWare durable LVAD
Capable of giving informed consent
Exclusion Criteria:
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandip Zalawadiya, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
St Vincent Hospital Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Vanderblt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27605222
Citation
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.
Results Reference
result
Learn more about this trial
Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device
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