The Real-World Effectiveness of The Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Failure: A Comparative Analysis to Standard of Care Pharmacologic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,150
- 试验地点
- 1
- 主要终点
- Composite of All-cause Mortality and Heart Failure Hospitalizations
研究概览
简要总结
This retrospective, non-randomized cohort study will evaluate how well the Cordella PA Sensor System works compared to standard medication treatment in people with chronic heart failure. The study will track patients for two years to see if those using the Cordella system have fewer deaths and hospitalizations related to heart failure.
详细描述
The study will compare two groups of patients with chronic heart failure:
- One group will use the Cordella PA Sensor System, which monitors heart pressure from home
- The other group will receive standard heart failure medications without a pressure monitoring system
The main goal is to see if patients using the Cordella system have fewer heart failure-related hospital stays and a lower death rate over a two-year period. The study will look especially closely at results for:
- Men and women separately
- Patients with different types of heart failure (preserved or reduced heart function)
- Patients aged 75 and older
- Different racial and ethnic groups
- Patients with kidney disease
- Patients with existing heart devices
The study will use real-world data from:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- •No implanted pulmonary artery sensor or monitoring at any time (Standard of Care Control Cohort only)
- •Record of temporary mechanical circulatory support during baseline period
- •Diagnosis of cardiogenic shock during baseline period
- •Receiving palliative care/hospice during baseline period
- •Record of end-stage renal disease during baseline period
- •Unable to take dual antiplatelet therapy or anticoagulants for one month post implant (Cordella Cohort only)
结局指标
主要结局
Composite of All-cause Mortality and Heart Failure Hospitalizations
时间窗: up to 24 months
* Description: The cumulative number of all-cause deaths and heart failure hospitalizations * Time Frame: 2 years after study entry (time zero) * Statistical Analysis Plan: The primary analysis will use an Andersen-Gill recurrent event model to account for multiple hospitalizations within individuals * Primary outcome will be assessed in the overall population
次要结局
- Composite Outcome in Racial and Ethnic Subgroups(up to 24 months)
- Composite Outcome in Patients with Chronic Kidney Disease(up to 24 months)
- Composite Outcome in Patients with Cardiac Devices(up to 24 months)
- Composite Outcome in Patients by Ejection Fraction(up to 24 months)
- Composite Outcome in Patients Age 75+(up to 24 months)