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.
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: * Patients using the Cordella system in routine medical care * Similar patients receiving standard care, identified through medical records and insurance claims Both groups of patients will be carefully matched to ensure they are similar in age, gender, and other important factors that could affect the results.
Study Type
OBSERVATIONAL
Enrollment
2,150
* Patients who receive the Cordella PA Sensor System for monitoring chronic heart failure * These patients will be monitored for 2 years after receiving the device * Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status
* Patients with chronic heart failure who receive standard medical care without PA pressure monitoring * These patients will be monitored for 2 years * Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status
Endotronix
Naperville, Illinois, United States
RECRUITINGComposite of All-cause Mortality and Heart Failure Hospitalizations
* 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
Time frame: up to 24 months
Composite Outcome in Racial and Ethnic Subgroups
The cumulative number of all-cause deaths and heart failure hospitalizations in: * Black/African American patients * Asian patients * Hispanic patients
Time frame: up to 24 months
Composite Outcome in Patients with Chronic Kidney Disease
The cumulative number of all-cause deaths and heart failure hospitalizations in patients with documented chronic kidney disease
Time frame: up to 24 months
Composite Outcome in Patients with Cardiac Devices
The cumulative number of all-cause deaths and heart failure hospitalizations in patients with indwelling cardiac implantable electronic devices
Time frame: up to 24 months
Composite Outcome in Patients by Ejection Fraction
The cumulative number of all-cause deaths and heart failure hospitalizations in patients with HF with reduced ejection fraction and patients with HF with preserved ejection fraction
Time frame: up to 24 months
Composite Outcome in Patients Age 75+
The cumulative number of all-cause deaths and heart failure hospitalizations in patients age 75+
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Time frame: up to 24 months