Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device

Stroke Clinical Trial

Official title:

Assessment of Lavare Cycle Implementation Among Patients Following HeartWare Left Ventricular Assist Device Implantation: A Prospective Randomized Controlled Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04199793
• Other study ID #: HeartWareLavare1
• Status: Terminated
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: August 10, 2021

Study information

• Verified date: November 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemolysis
• Stroke
• Thromboembolism

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	St Vincent Hospital Indianapolis	Indianapolis	Indiana
United States	Vanderblt University Medical Center	Nashville	Tennessee
United States	Advocate Christ Medical Center	Oak Lawn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & 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 pra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause Mortality	death from any cause	6 months
Secondary	Survival to Transplantation	Number of days supported on LVAD until transplant	6 months
Secondary	Rehospitalizations	Any cardiac and non-cardiac re-hospitalizations since trial enrollment	6 months
Secondary	Mucosal Bleeding	Epistaxis, gastrointestinal bleeding, urological bleeding events will be analyzed	6 months
Secondary	Right Ventricular Failure	INTERMACS definitions for Right ventricular failure will be analyzed	6 months
Secondary	Device Related Infection	LVAD device systems related infections will be analyzed	6 months
Secondary	Aortic Insufficiency	Echocardiographic evidence will be used to define severity of aortic insufficiency	6 months
Secondary	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.	Baseline to 6 months
Secondary	Changes in New York Heart Association Class	Functional class will be assessed at baseline and during follow up to assess improvement in functional status	Baseline to 6 months
Secondary	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.	6 months