Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device

Vanderbilt University Medical Center

Status: Terminated

Conditions: Hemolysis; Thromboembolism; Stroke

Treatments: Device: Lavare Off; Device: Lavare On

Study type: Interventional

Funder types: Other

Identifiers

NCT04199793

HeartWareLavare1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Lavare Cycle On

Active Comparator group

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.

Treatment:

Device: Lavare On

Lavare Cycle Off

Active Comparator group

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.

Treatment:

Device: Lavare Off