Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device

NCT ID: NCT04199793

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2021-08-10

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.

Conditions

Thromboembolism; Hemolysis; Stroke

Keywords

Lavare Cycle; HeartWare LVAD; Thromboembolic events

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lavare On

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Lavare Off

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sandip Zalawadiya

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandip Zalawadiya, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

St Vincent Hospital Indianapolis

Indianapolis, Indiana, United States

Vanderblt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27605222 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HeartWareLavare1

Identifier Type: -

Identifier Source: org_study_id