Clinical trial NCT04199793: 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
Overall status: TERMINATED
Phase: NA
Conditions: Thromboembolism
Hemolysis
Stroke
Keywords: Lavare Cycle
HeartWare LVAD
Thromboembolic events
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Approved for or supported with HeartWare durable LVAD
3. Capable of giving informed consent

Exclusion Criteria:

1. For those undergoing new device implantation:

   1. Age \<18 years
   2. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 at the time of implantation
   3. Presence of intra-cardiac thrombus
   4. History of thromboembolic event within previous 3 months of enrollment
2. For those with prior LVAD implantation with on-going support:

   1. Support duration \<3 months
   2. History of prior LVAD pump exchange
   3. History of LVAD pump hemolysis or thrombosis as defined by INTERMACS criteria
   4. History of stroke or transient ischemic event within previous 3 months of enrollment
   5. History of post-LVAD severe right ventricular failure as defined by INTERMACS criteria within previous 3 months of enrollment
   6. History of pump-related infection treated within previous 3 months of enrollment or those on chronic antibiotics suppressive therapy for pump related infection
   7. History of post-LVAD intra-cardiac or arterial thrombus or thromboembolic event within previous 3 months of enrollment
   8. International Normalized Ratio (INR) \<2 within previous 30-days from the date of enrollment
   9. Aspirin dose \<325 mg/day
   10. Lactate Dehydrogenase (LDH) levels ≥ 3 times the upper normal limit in previous 3 months

Primary outcomes:
measure: Composite Endpoint of Total Ischemic Events, Thromboembolic Events, Pump Hemolysis or Thrombosis, Pump Exchange
timeFrame: 6 months
Secondary outcomes:
measure: All-cause Mortality
timeFrame: 6 months
measure: Survival to Transplantation
timeFrame: 6 months
measure: Rehospitalizations
timeFrame: 6 months
measure: Mucosal Bleeding
timeFrame: 6 months
measure: Right Ventricular Failure
timeFrame: 6 months
measure: Device Related Infection
timeFrame: 6 months
measure: Aortic Insufficiency
timeFrame: 6 months
measure: Change in 6 Minute Walk Test
timeFrame: Baseline to 6 months
measure: Changes in New York Heart Association Class
timeFrame: Baseline to 6 months
measure: Quality of Life Measured by The Kansas City Cardiomyopathy Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St Vincent Hospital Indianapolis
state: Indiana
city: Nashville
country: United States
facility: Vanderblt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sandip Zalawadiya, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.