Protective Strategies to Mitigate Post-Operative Right Ventricular (PV) Dysfunction After Centrifugal Flow Durable Left Ventricular Assist Device (LVAD) Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3
研究概览
简要总结
This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.
详细描述
The main purpose of this study is to learn more about protecting against RV dysfunction and RV failure (RVF) in patients receiving LVAD implantations.
This is a prospective, randomized controlled study that will include 20 patients with heart failure undergoing LVAD implantation. Patients will receive their LVAD implantation as part of routine care. Patients will be randomized 1:1 to one of two arms, 1) standardized RV management arm, and 2) usual care RV management arm, which are both consistent with standard of care (SOC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Undergoing durable LVAD implantation without plan for perioperative right ventricular mechanical circulatory support
排除标准
- •Patients with pre-operative right ventricular mechanical circulatory support or having high likelihood of requiring right ventricular mechanical circulatory support.
- •Patients with RV implantable cardiac device (ICD)/pacemaker lead who are pacemaker-dependent
- •Pregnant patients
研究组 & 干预措施
Standardized RV Management
Physicians will follow prespecified parameters for RV management (consistent with SOC)
干预措施: Standardized RV Management (Other)
Usual Care RV Management
Physicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC)
干预措施: Usual Care RV Management (Other)
结局指标
主要结局
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3
时间窗: Baseline, Day 3
RAP measured by pulmonary artery catheter
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7
时间窗: Baseline, Day 7
RAP measured by pulmonary artery catheter
Change in right atrial pressure (RAP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
时间窗: Baseline, end of hemodynamic monitoring (about Day 10)
RAP measured by pulmonary artery catheter
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 3
时间窗: Baseline, Day 3
RAP/PCWP measured by pulmonary artery catheter
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 7
时间窗: Baseline, Day 7
RAP/PCWP measured by pulmonary artery catheter
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 3
时间窗: Baseline, Day 3
PAPI measured by pulmonary artery catheter
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
时间窗: Baseline, end of hemodynamic monitoring (about Day 10)
PAPI measured by pulmonary artery catheter
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 3
时间窗: Baseline, Day 3
RVSWI measured by pulmonary artery catheter
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 7
时间窗: Baseline, Day 7
RVSWI measured by pulmonary artery catheter
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
时间窗: Baseline, end of hemodynamic monitoring (about Day 10)
RAP/PCWP measured by pulmonary artery catheter
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7
时间窗: Baseline, Day 7
PAPI measured by pulmonary artery catheter
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
时间窗: Baseline, end of hemodynamic monitoring (about Day 10)
RVSWI measured by pulmonary artery catheter
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 3
时间窗: Baseline, Day 3
CPO measured by pulmonary artery catheter
Change in cardiac power output (CPO) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
时间窗: Baseline, end of hemodynamic monitoring (about Day 10)
CPO measured by pulmonary artery catheter
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7
时间窗: Baseline, Day 7
CPO measured by pulmonary artery catheter
次要结局
- Number of individuals with acute kidney injuries requiring renal replacement therapy(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Number of individuals with transient ischemic attacks [TIA] or cerebrovascular accidents [CVA](Through duration of hospitalization, up to 30 days following LVAD implantation)
- Inotropic therapy(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Vasopressor therapy(Through duration of hospitalization, up to 30 days following LVAD implantation)
- RV failure defined by the 2014 Interagency Registry for Mechanical Circulatory Support (INTERMACS)(Through duration of hospitalization, up to 30 days following LVAD implantation)
- RV failure defined by the 2020 Academic Research Consortium (ARC)(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Total time on inhaled nitric oxide(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Number of individuals who experience all-cause mortality(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Number of individuals with an arrhythmia requiring medical team intervention(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Number of individuals who need tracheostomy(Through duration of hospitalization, up to 30 days following LVAD implantation)
- ICU length of stay(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Hospital length of stay(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Number of individuals needing percutaneous endoscopic gastrostomy tube(Through duration of hospitalization, up to 30 days following LVAD implantation)