Long-Term Survival After Left Ventricular Assist Device Support (LVAD) Implantation in Patients With End-Stage Heart Failure: A Prospective, Observational, Multi-Center Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Clinical response after LVAD implantation
研究概览
简要总结
This is a prospective, observational, multi-center cohort study designed to evaluate long-term survival and clinical outcomes in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation.
Patients receiving LVAD implantation as part of routine clinical care will be enrolled and followed for up to 3-5 years. During the study period, data will be collected on baseline characteristics, preoperative medical therapy, intraoperative surgical information, in-hospital course, and long-term postoperative medication use, as well as survival status, major clinical outcomes, LVAD-related complications, and hospital readmissions.
In addition, myocardial tissue samples will be obtained from the left ventricular apex during LVAD implantation surgery. These tissue samples are routinely removed as part of the standard surgical procedure and would otherwise be discarded after pathological examination. Peripheral blood samples will also be collected at predefined time points as part of routine clinical blood testing. No additional surgical procedures or invasive interventions are required for this study.
This study does not involve any experimental treatment or changes to standard medical care. All treatments and follow-up assessments are determined by the treating physicians according to routine clinical practice.
The purpose of this study is to improve understanding of long-term outcomes after LVAD implantation and to explore potential biological factors associated with prognosis in patients with end-stage heart failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years
- •Diagnosis of end-stage heart failure refractory to optimal medical therapy
- •Scheduled to undergo left ventricular assist device (LVAD) implantation as part of routine clinical care
- •Able to provide written informed consent for participation and biospecimen collection
- •Willing and able to comply with study procedures and long-term follow-up
- •Availability of left ventricular apical myocardial tissue obtained during LVAD implantation surgery
- •Availability of peripheral blood samples collected during routine clinical care
- •Patients treated at participating study centers
排除标准
- •Age <18 years
- •Prior implantation of a durable mechanical circulatory support device
- •Concomitant heart transplantation at the time of index surgery
- •Congenital heart disease requiring complex surgical repair
- •Active systemic infection or sepsis at the time of LVAD implantation
- •Known active malignancy with a life expectancy <1 year
- •Severe non-cardiac comorbidities limiting expected survival to less than 1 year (e.g., advanced liver failure, end-stage renal disease not eligible for renal replacement therapy)
- •Inability or unwillingness to provide informed consent
- •Pregnancy or breastfeeding at the time of enrollment
- •Inadequate quantity or quality of myocardial tissue or peripheral blood samples for planned analyses
结局指标
主要结局
Clinical response after LVAD implantation
时间窗: During longitudinal follow-up up to 5 years after LVAD implantation
Patients will be classified as responders or non-responders based on predefined criteria.
次要结局
- Genetic and molecular correlates of clinical response after LVAD implantation(Assessed during follow-up up to 3-5 years after LVAD implantation)