Assessment of Lavare Cycle Implementation Among Patients Following HeartWare Left Ventricular Assist Device Implantation: A Prospective Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 8
- 主要终点
- Composite Endpoint of Total Ischemic Events, Thromboembolic Events, Pump Hemolysis or Thrombosis, Pump Exchange
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Approved for or supported with HeartWare durable LVAD
- •Capable of giving informed consent
排除标准
- •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
- •Lactate Dehydrogenase (LDH) levels ≥ 3 times the upper normal limit in previous 3 months
结局指标
主要结局
Composite Endpoint of Total Ischemic Events, Thromboembolic Events, Pump Hemolysis or Thrombosis, Pump Exchange
时间窗: 6 months
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
次要结局
- All-cause Mortality(6 months)
- Survival to Transplantation(6 months)
- Rehospitalizations(6 months)
- Mucosal Bleeding(6 months)
- Right Ventricular Failure(6 months)
- Device Related Infection(6 months)
- Aortic Insufficiency(6 months)
- Change in 6 Minute Walk Test(Baseline to 6 months)
- Changes in New York Heart Association Class(Baseline to 6 months)
- Quality of Life Measured by The Kansas City Cardiomyopathy Questionnaire(6 months)
研究者
Sandip Zalawadiya
Assistant Professor of Medicine
Vanderbilt University Medical Center