Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device

N/ATerminatedNCT04199793

Vanderbilt University Medical Center9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

All-cause Mortality

death from any cause

Time frame: 6 months

Survival to Transplantation

Number of days supported on LVAD until transplant

Time frame: 6 months

Rehospitalizations

Any cardiac and non-cardiac re-hospitalizations since trial enrollment

Time frame: 6 months

Mucosal Bleeding

Epistaxis, gastrointestinal bleeding, urological bleeding events will be analyzed

Time frame: 6 months

Right Ventricular Failure

INTERMACS definitions for Right ventricular failure will be analyzed

Time frame: 6 months

Device Related Infection

LVAD device systems related infections will be analyzed

Time frame: 6 months

Aortic Insufficiency

Echocardiographic evidence will be used to define severity of aortic insufficiency

Time frame: 6 months

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.

Time frame: Baseline to 6 months

Changes in New York Heart Association Class

Functional class will be assessed at baseline and during follow up to assess improvement in functional status

Time frame: Baseline to 6 months

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.

Time frame: 6 months

Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes