Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device

NCT04199793 | Terminated Results FDA Device

• 1 other identifier: HeartWareLavare1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

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.

Conditions

Thromboembolism; Hemolysis; Stroke

Keywords

Lavare Cycle; HeartWare LVAD; Thromboembolic events

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (10)

• All-cause Mortality

  6 months

• Survival to Transplantation

  6 months

• Rehospitalizations

  6 months

• Mucosal Bleeding

  6 months

• Right Ventricular Failure

  6 months

Study Arms (2)

Lavare Cycle On

ACTIVE COMPARATOR

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.

Device: Lavare On

Lavare Cycle Off

ACTIVE COMPARATOR

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.

Device: Lavare Off

Interventions

Lavare On 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 On

Lavare Off 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.

Lavare Cycle Off

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Approved for or supported with HeartWare durable LVAD
• Capable of giving informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

St Vincent Hospital Indianapolis

Indianapolis, Indiana, 46290, United States

Location

Vanderblt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 27605222 RESULT

MeSH Terms

Conditions

Thromboembolism; Hemolysis; Stroke

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

The study was terminated early due to the sponsor withdrew the device off market.

Results Point of Contact

• Title: Sandip Zalawadiya, MBBS
• Organization: Vanderbilt University Medical Center

sandip.k.zalawadiya@vumc.org

6159368187

Study Officials

• Sandip Zalawadiya, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: August 10, 2020
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: December 12, 2022
• Results First Posted: December 12, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)