Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively
研究概览
简要总结
The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation. The study will be a randomized trial for patients presenting for LVAD implantation to either tricuspid valve repair or no tricuspid valve repair. The data will be analyzed as both an intention to treat analysis as well as an "as treated" analysis with the primary outcome being rates of right ventricular dysfunction post LVAD implantation. Tricuspid valve repair for these patient is currently being done for some patients, without any strong data to either support such practice or negate it.
详细描述
This study is a prospective, single center, randomized trial. Up to 280 subjects will be enrolled.
Inclusion Criteria - Potential subjects must meet all inclusion criteria to participate.
- Planned LVAD implantation (either destination or bridge indication)
- 18 years of age or older
- Patients wilith mild tricuspid regurgitation (TR) during surgical planning will be screened for meeting inclusion criteria for this study.
- TR on pre-operative echo (within one week of procedure) (TTE or intraoperative TEE) quantified as moderate or severe with normal tricuspid valve leaflets
Exclusion Criteria
- Previous tricuspid valve surgery
- Previous LVAD
- Planned concurrent right ventricular assist device (RVAD) or extracorporeal membrane oxygenation (ECMO) at the time of LVAD operation or during the same hospitalization
- Preimplant RVAD or ECMO
- Planned thoracotomy approach for LVAD implantation
- Pregnant women
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
- •Planned LVAD implantation (either destination or bridge indication)
- •18 years of age or older
- •Patients will mild tricuspid regurgitation (TR) during surgical planning will be screened for meeting inclusion criteria for this study.
- •Patients with moderate or graeter TR on pre-operative echo (within one week of procedure) (TTE or intraoperative TEE) will qualify for randomization
排除标准
- •Previous tricuspid valve surgery
- •Previous left ventricular assist device
- •Planned concurrent right ventricular assist device (RVAD) or extracorporeal membrane oxygenation (ECMO) at the time of LVAD operation or during the same hospitalization
- •Preimplant RVAD or ECMO
- •Pregnant women
结局指标
主要结局
Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively
时间窗: 6 months post-operatively
Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria
Proportion of patients experiencing moderate or greater right heart failure at 12 months post-operatively
时间窗: 12 months post-operatively
Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria
次要结局
未报告次要终点